Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-01 @ 8:09 AM
Study NCT ID:
NCT03138603
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2017-04-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metoprolol to Reduce Perioperative Myocardial Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pnagele@uchicagomedicine.org', 'phone': '773-795-3544', 'title': 'Peter Nagele, MD, MSc', 'organization': 'University of Chicago Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected and assessed during study phase participation, e.g., intervention administration, and daily post-operative follow-up, up to 30-days post-operative.', 'eventGroups': [{'id': 'EG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).\n\nPost-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 8, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).\n\nPost-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 3, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bradycardia Event', 'notes': 'A recorded period when heart rate was below 60-beats per minute.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension event', 'notes': 'A recorded period when systolic blood pressure reading was lower than 90 mm Hg.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'MACE events', 'notes': 'a composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death (e.g., Myocardial Infarction, Cardiac arrest, Stroke.)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effectiveness of Beta-blocker Therapy Reducing Post-operative Myocardial Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).\n\nPost-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).\n\nPost-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 days, following surgery', 'description': 'Measured effectiveness of post-operative beta-blocker therapy to reduce myocardial injury by monitoring daily biomarkers (High-Sensitivity cardiac Troponin \\[HS-cTn\\]).\n\nDaily post-operative biomarker (hs-cTn) measurements to determine myocardial injury.\n\nMyocardial injury is defined as a new hscTn elevation \\>99th percentile, or a 50% increase if the baseline hscTn is already elevated \\>99th percentile', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is comprised of participants meeting criteria for randomization to receive intervention, with biomarker (hs-cTn) showing increased value(s).'}, {'type': 'SECONDARY', 'title': 'Effectiveness in Reduction of Major Adverse Cardiac Events (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 days, following surgery', 'description': 'MACE are defined as myocardial ischemia (MI), cardiac death or coronary revascularization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MACE analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, having myocardial ischemia, cardiac death, or coronary revascularization.'}, {'type': 'SECONDARY', 'title': 'Monitor Post-operative Myocardial Ischemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-3 days, following surgery', 'description': 'Post-operative cardiac monitoring via ECG to evaluate if myocardial ischemia is present.\n\nMyocardial Ischemia is defined as ST depression or elevation of ≥0.2 mV in one lead or ≥0.1 mV in two contiguous leads lasting ≥10 min', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, with post-operative cardiac monitoring (ECG), showing myocardial ischemia is present.\n\nMyocardial Ischemia is defined as ST depression or elevation of ≥0.2 mV in one lead or ≥0.1 mV in two contiguous leads lasting ≥10 min'}, {'type': 'SECONDARY', 'title': 'Number of Stroke Related Events Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-3 days, following surgery', 'description': 'Stroke will be defined as focal or global cerebral, spinal, or retinal dysfunction of sudden onset', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, with post-operative sudden onset of neurological effects from cerebral dysfunction.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Having Vasopressor Therapy to Regulate Symptomatic Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-3 days, following surgery', 'description': 'Monitor participants with vasopressor requirements for blood pressure regulation due to symptomatic hypotension (rate/duration time).\n\nSymptomatic hypotension (systolic BP \\< 90 mmHg) can be determined by clinical intervention due to low blood pressure and/or patient developed clinical symptoms due to hypotension.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, having significant post-operative hypotension (systolic BP \\< 90 mmHg), requiring therapeutic intervention (vasopressor).'}, {'type': 'SECONDARY', 'title': 'Number of Participant Incidence of Clinically Relevant Bradycardia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-3 days, following surgery', 'description': 'Monitored participants with cumulative events of bradycardia (rate/duration time).\n\nBradycardia is defined as low heart rate (HR \\< 50/min).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants Number of Days Spent Post-operative Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'classes': [{'title': 'Participant post-operative hospitalization in days', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Participant post-operative Intensive Care Unit (ICU) hospitalization in days', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-3 days following surgery', 'description': 'Measurement of participants number of days spent hospitalized (0-3 days) following surgery.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, with post-operative length of hospital stay in days.'}, {'type': 'SECONDARY', 'title': 'Patient Recovery Progress Events at 30-days Post-operative.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-days from surgery', 'description': 'Measured number of participant post-operative recovery events, 30-days following the surgical procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, with post-operative 1-month follow up showing readmission since surgical discharge.'}, {'type': 'SECONDARY', 'title': 'Participant Post-operative Mortality at 1-year Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-Year from surgery', 'description': "Measured number of patient post-operative mortality at 1-year.\n\nMeasured by 'living', 'deceased', 'date of death'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, deceased within 1-year of post-operative discharge.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Measured Number of Patient Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'classes': [{'title': 'Hypotension', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Arrest', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-operatively, 0-3 days, and day-30', 'description': "Number of measured participant adverse events and severity associated with low blood pressure (hypotension), low heart heart (bradycardia), nausea and vomiting; or other symptoms determined 'probably', 'possibly', 'unrelated', or 'related' to the study intervention. This includes any unplanned escalation of care admissions (e.g., Intensive Care Unit \\[ICU\\]).\n\nStudy patient safety is monitored by the investigators (MD) with experience in critical care anesthesia, as well as an experienced clinical research team responsible for data collection and reporting of events.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, having post-operative adverse events.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nMetoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).\n\nPlacebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-28', 'size': 646872, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-01T15:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double blind masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, double blinded placebo controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'dispFirstSubmitDate': '2023-08-16', 'completionDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2017-04-26', 'resultsFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2017-04-28', 'dispFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-03', 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measured Number of Patient Adverse Events', 'timeFrame': 'Post-operatively, 0-3 days, and day-30', 'description': "Number of measured participant adverse events and severity associated with low blood pressure (hypotension), low heart heart (bradycardia), nausea and vomiting; or other symptoms determined 'probably', 'possibly', 'unrelated', or 'related' to the study intervention. This includes any unplanned escalation of care admissions (e.g., Intensive Care Unit \\[ICU\\]).\n\nStudy patient safety is monitored by the investigators (MD) with experience in critical care anesthesia, as well as an experienced clinical research team responsible for data collection and reporting of events."}], 'primaryOutcomes': [{'measure': 'Effectiveness of Beta-blocker Therapy Reducing Post-operative Myocardial Injury', 'timeFrame': '0-3 days, following surgery', 'description': 'Measured effectiveness of post-operative beta-blocker therapy to reduce myocardial injury by monitoring daily biomarkers (High-Sensitivity cardiac Troponin \\[HS-cTn\\]).\n\nDaily post-operative biomarker (hs-cTn) measurements to determine myocardial injury.\n\nMyocardial injury is defined as a new hscTn elevation \\>99th percentile, or a 50% increase if the baseline hscTn is already elevated \\>99th percentile'}], 'secondaryOutcomes': [{'measure': 'Effectiveness in Reduction of Major Adverse Cardiac Events (MACE)', 'timeFrame': '0-3 days, following surgery', 'description': 'MACE are defined as myocardial ischemia (MI), cardiac death or coronary revascularization'}, {'measure': 'Monitor Post-operative Myocardial Ischemia', 'timeFrame': '0-3 days, following surgery', 'description': 'Post-operative cardiac monitoring via ECG to evaluate if myocardial ischemia is present.\n\nMyocardial Ischemia is defined as ST depression or elevation of ≥0.2 mV in one lead or ≥0.1 mV in two contiguous leads lasting ≥10 min'}, {'measure': 'Number of Stroke Related Events Following Surgery', 'timeFrame': '0-3 days, following surgery', 'description': 'Stroke will be defined as focal or global cerebral, spinal, or retinal dysfunction of sudden onset'}, {'measure': 'Number of Participants Having Vasopressor Therapy to Regulate Symptomatic Hypotension', 'timeFrame': '0-3 days, following surgery', 'description': 'Monitor participants with vasopressor requirements for blood pressure regulation due to symptomatic hypotension (rate/duration time).\n\nSymptomatic hypotension (systolic BP \\< 90 mmHg) can be determined by clinical intervention due to low blood pressure and/or patient developed clinical symptoms due to hypotension.'}, {'measure': 'Number of Participant Incidence of Clinically Relevant Bradycardia', 'timeFrame': '0-3 days, following surgery', 'description': 'Monitored participants with cumulative events of bradycardia (rate/duration time).\n\nBradycardia is defined as low heart rate (HR \\< 50/min).'}, {'measure': 'Participants Number of Days Spent Post-operative Hospitalization', 'timeFrame': '0-3 days following surgery', 'description': 'Measurement of participants number of days spent hospitalized (0-3 days) following surgery.'}, {'measure': 'Patient Recovery Progress Events at 30-days Post-operative.', 'timeFrame': '30-days from surgery', 'description': 'Measured number of participant post-operative recovery events, 30-days following the surgical procedure.'}, {'measure': 'Participant Post-operative Mortality at 1-year Following Surgery', 'timeFrame': '1-Year from surgery', 'description': "Measured number of patient post-operative mortality at 1-year.\n\nMeasured by 'living', 'deceased', 'date of death'."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'heart disease', 'metoprolol', 'myocardial injury', 'coronary artery disease'], 'conditions': ['Heart Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to test if a commonly used, FDA-approved medication, called metoprolol, given at the conclusion of anesthesia following surgery, and during postoperative admission, reduces the possibility of heart related complications in patients with coronary artery disease (CAD).', 'detailedDescription': 'All enrolled patients will be beta-blocker naïve for at least 30-days prior to their scheduled surgical procedure. Study patients will be randomly assigned to an interventional drug arm (metoprolol tartrate vs placebo-comparator). At the conclusion of anesthesia following the surgical procedure, patients hemodynamically stable and meeting study safety parameters (heart rate greater-than-65; systolic blood pressure greater-than-110) will receive 3-intravenous doses of interventional study drug (metoprolol tartrate 5mg or placebo-comparator), based on previously assigned study arm; then, patients remaining hemodynamically stable will receive an oral dose (25mg metoprolol vs placebo-comparator) approximately every 8-hours for up to 3-days during postoperative hospital admission.\n\nFrom arrival in the preop holding area through up to 72 hours postoperative admission to hospital discharge or end of study treatment (whichever occurs first), patients will be continuously monitored through medical records assessments, Holter monitoring, mobile hemodynamic monitoring (VisiMobile), and in-person daily follow-up visits that include 12-lead ECG, and blood collections for serial cardiac biomarkers for high-sensitivity troponin.\n\nAdditional study patient postoperative assessment will be performed at 30 days and 1 year after surgery. These can be completed by interview and/or medical record review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Age \\>= 50 years\n2. Beta-blocker naïve \\[30 days prior to surgery\\]\n3. Previously diagnosed coronary artery disease (CAD), or\n\n 1. History of peripheral vascular disease (PVD), or\n 2. Chronic kidney disease (CKD) \\[eGFR ≤60ml/min\\], or\n 3. History of positive stress test or\n 4. At high risk for CAD (must meet at least 2 criteria):\n\n i. Age \\>= 70 years ii. Hypertension iii. Diabetes requiring oral medication or insulin iv. Current smoker or some days smoker within the past 2 years\n4. Major non-cardiac, elective surgery under general anesthesia\n\nExclusion Criteria\n\nSubjects will not be enrolled if any of the following criteria exist:\n\n1. History of stroke, or transient ischemic attack (TIA)\n2. Previously diagnosed carotid disease, i.e., either 70% unilateral or 50% bilateral carotid occlusion.\n3. Heart rate \\<=55bpm\n4. Congestive heart failure with New York Heart Association(NYHA) Functional Classification of III-IV or left ventricular heart failure with ejection fraction ≤50%\n5. Severe valvular regurgitation\n6. Second or third degree atrioventricular (AV) block without pacemaker\n7. Active asthma or chronic obstructive pulmonary disease (COPD) with symptoms or resolving symptoms on day of surgery\n8. Anemia \\[HB\\<=9g/dL\\]\n9. Allergy to beta-blockade drugs\n10. Unwilling or unable to give consent for participation\n11. Undergoing any carotid endarterectomy, endovascular, endoscopic, superficial, or ambulatory procedures\n12. Pregnancy or lactating women\n13. Prisoners'}, 'identificationModule': {'nctId': 'NCT03138603', 'acronym': 'ORION', 'briefTitle': 'Metoprolol to Reduce Perioperative Myocardial Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Metoprolol to Reduce Perioperative Myocardial Injury', 'orgStudyIdInfo': {'id': 'IRB19-1797'}, 'secondaryIdInfos': [{'id': '5R01HL126892', 'link': 'https://reporter.nih.gov/quickSearch/5R01HL126892', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metoprolol', 'description': 'Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).', 'interventionNames': ['Drug: Metoprolol Tartrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metoprolol Tartrate', 'type': 'DRUG', 'otherNames': ['Beta-blocker'], 'description': 'Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).', 'armGroupLabels': ['Metoprolol']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sham', 'Placebo-comparator', 'Control'], 'description': 'Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Peter Nagele, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}