Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2026-01-13 @ 5:13 AM
Study NCT ID:
NCT02096406
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-22', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ACE or ARB use at hospital discharge', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 7 days'}, {'measure': 'Duration of post-operative mechanical ventilation', 'timeFrame': '7 days', 'description': 'Time to extubation after admission to ICU'}, {'measure': 'Cardiovascular ICU length of stay', 'timeFrame': 'Participants will be followed for the duration of the ICU stay, an expected average of 2 days'}, {'measure': 'ICU readmission', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 7 days', 'description': 'Incidence and cause of any ICU readmission after discharge to lower acuity ward post-operatively.'}], 'primaryOutcomes': [{'measure': 'Adherence to the study protocol', 'timeFrame': 'From randomization to surgery', 'description': 'Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized'}, {'measure': 'Feasibility of study enrollment', 'timeFrame': '30 dasys', 'description': '\\>50% of eligible patients are successfully enrolled in the trial'}, {'measure': 'Feasibility of Study', 'timeFrame': '60 days', 'description': '\\>=95% completeness of outcomes'}], 'secondaryOutcomes': [{'measure': 'Feasibility of the Study', 'timeFrame': '30 days', 'description': 'Reasons for non-recruitment'}, {'measure': 'Incidence of post operative Shock', 'timeFrame': '3 hours', 'description': 'Post-operative shock (use of any intravenous vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, and/or methylene blue) and mechanical support devices (left ventricular assist devices, intra-aortic balloon pumps, or extracorporeal membrane oxygenation) initiated within the first 3 hours of CVICU admission)'}, {'measure': 'Duration of Shock', 'timeFrame': '7 days', 'description': 'Post-operative shock (use of any intravenous vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, and/or methylene blue) and mechanical support devices (left ventricular assist devices, intra-aortic balloon pumps, or extracorporeal membrane oxygenation) initiated within the first 3 hours of CVICU admission)'}, {'measure': 'Vasopressors use', 'timeFrame': '7 days', 'description': 'Number and maximum dose of vasopressors'}, {'measure': 'Post operative intravenous anti-hypertensive use', 'timeFrame': '7 days', 'description': 'The post-operative use intravenous vasodilators (nitroglycerine or nitroprusside)'}, {'measure': 'Duration of intravenous vasodilator use', 'timeFrame': '7 days', 'description': 'The post-operative duration intravenous vasodilators (nitroglycerine or nitroprusside)'}, {'measure': 'Vasodilator use', 'timeFrame': '7 days', 'description': 'The number and maximum dose of vasodilators'}, {'measure': 'Incidence of vasoplegic shock', 'timeFrame': '4 hours', 'description': 'Vasopressor administration for at lead 4 hours despite intravenous fluid administration'}, {'measure': 'Pre-operative heart failure deterioration', 'timeFrame': '48 hours', 'description': 'Any increase in diuretic dose in 48 hours prior to surgery'}, {'measure': 'Post-operative acute kidney injury', 'timeFrame': '7 days', 'description': 'Acute kidney injury defined as a doubling of serum creatinine within 7 days of surgery'}, {'measure': 'Change in renal function', 'timeFrame': '7 days', 'description': 'Difference between baseline and peak post-operative creatinine'}, {'measure': 'Initiation of renal replacement therapy', 'timeFrame': '7 days'}, {'measure': 'Peak post-operative troponin', 'timeFrame': '72 hours', 'description': 'Peak post-operative troponin within 72 hours of surgery'}, {'measure': 'Stroke', 'timeFrame': '30 days', 'description': 'Incidence of any stroke within 30 days of surgery'}, {'measure': 'In hospital Mortality', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Coronary artery bypass grafting', 'angiotensin converting enzyme inhibitor', 'angiotensin receptor blocker', 'Surgical valve repair', 'Valve Replacement'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '30371293', 'type': 'DERIVED', 'citation': 'van Diepen S, Norris CM, Zheng Y, Nagendran J, Graham MM, Gaete Ortega D, Townsend DR, Ezekowitz JA, Bagshaw SM. Comparison of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Management Strategies Before Cardiac Surgery: A Pilot Randomized Controlled Registry Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009917. doi: 10.1161/JAHA.118.009917.'}]}, 'descriptionModule': {'briefSummary': 'Coronary artery disease is a leading cause of death, hospitalization, and health care costs in developed nations. Coronary revascularization with coronary artery bypass graft (CABG) surgery improves the long term survival in patients with diabetes and multi-vessel disease. Angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) reduce mortality and subsequent cardiac events in patients with coronary artery disease undergoing CABG surgery when initiated at least 4 weeks pre-operatively. Observational data have suggested that pre-operative ACE administration is associated with an increased risk of post-operative vasoplegic shock, acute kidney injury, and mortality; however, other studies have failed to confirm these findings and further suggested ACE are associated with a reduced risk of peri-operative myocardial infarction. A single trial of 40 CABG patients randomized to pre-operative ACE withdrawal or continuation reported that the withdrawal group required significantly fewer vasopressors during cardiopulmonary bypass but more intravenous vasodilators post-operatively to control hypertension. Hence, it remains unclear whether ACEs should be held or continued immediately prior to CABG surgery and a survey of cardiac surgeons suggests that current clinical practice is divided. This pilot study aims to establish the feasibility of the study design and to determine the frequency of clinical endpoints among patients who continue and discontinue ACE prior to cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective or urgent isolated CABG and/or valvular repari or replacement surgery\n* On an ACE or ARB for a minimum of 7 days\n\nExclusion Criteria:\n\n* Emergency surgery\n* Pre-operative shock (defined as systolic blood pressure \\< 90 mmHg, the need for any vasopressor or inotropic support, or a mechanical cardiac support device)\n* Severe uncontrolled pre-operative hypertension (defined as blood pressure ≥ 200 mmHg systolic or ≥120mmHg diastolic mmHG or the pre-operative need for intravenous anti-hypertensive agents)\n* ACE or ARB therapy \\< 7 days\n* Any mineralocorticoid receptor antagonist therapy.'}, 'identificationModule': {'nctId': 'NCT02096406', 'acronym': 'COMPACT', 'briefTitle': 'Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study', 'orgStudyIdInfo': {'id': 'Pro00042749'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ACE/ARB Continuation', 'description': 'ACE/ARB will be continued up to and including the morning of surgery.', 'interventionNames': ['Drug: ACE/ARB continuation']}, {'type': 'OTHER', 'label': 'ACE/ARB withdrawal', 'description': 'ACE/ARB will be discontinued medication 48 hours prior to surgery', 'interventionNames': ['Drug: ACE/ARB withdrawal']}], 'interventions': [{'name': 'ACE/ARB continuation', 'type': 'DRUG', 'description': 'ACE/ARB will be taken the morning of surgery with a sip of water', 'armGroupLabels': ['ACE/ARB Continuation']}, {'name': 'ACE/ARB withdrawal', 'type': 'DRUG', 'description': 'ACE/ARB will be stopped 48 hours prior to surgery', 'armGroupLabels': ['ACE/ARB withdrawal']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Sean van Diepen, MD, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Critical Care Medicine and Cardiology', 'investigatorFullName': 'Sean van Diepen', 'investigatorAffiliation': 'University of Alberta'}}}}