Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-08 @ 11:20 AM
Study NCT ID:
NCT02021760
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2013-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], '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'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Global left ventricular function determined by left ventricular ejection fraction determined by CMR.', 'timeFrame': '4-7 days and 6 months following index event'}, {'measure': 'Microvascular obstruction determined by CMR', 'timeFrame': '4-7 days following index event'}, {'measure': 'Quantified ECV (extracellular volume) in left ventricular as myocardium at risk', 'timeFrame': '4-7 days following index event'}, {'measure': 'Myocardial infarct size by CMR expressed as a percentage to the myocardium at risk determined by Bari or modified Approach Score with coronary angiography.', 'timeFrame': '5-7 days following index event'}], 'primaryOutcomes': [{'measure': 'Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance', 'timeFrame': '4-7 days following index event'}], 'secondaryOutcomes': [{'measure': 'Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance', 'timeFrame': '6 months following index event'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': '* Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.\n* Trial Design: Placebo controlled randomized study with parallel groups\n* Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7\n* Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.\n* Global left ventricular function determined by left ventricular ejection fraction determined by CMR.\n* Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.\n* Safety Parameters: Major adverse cardiovascular events.', 'detailedDescription': 'See above. 3 patients left to include.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient planned for primary PCI.\n* Chest pain indicating myocardial ischemia with a duration \\>30 minutes and \\< 6 hours prior to randomization.\n* ST elevations \\>0.1 mV (\\>0.2 mV in V2-V3) in \\> two contiguous leads in V1-V6.\n* Informed consent.\n\nExclusion Criteria:\n\n* Previous myocardial infarction based on medical history or Q-wave on ECG in other area\n* Left Bundle Branch Block on ECG.\n* Previous CABG\n* Cardiac arrest\n* Any contraindication for CMR.\n* Clinical symptoms of claudication\n* Treatment with glibenclamide or cyclosporine on admission.\n* Any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.'}, 'identificationModule': {'nctId': 'NCT02021760', 'acronym': 'RECOND', 'briefTitle': 'Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)', 'orgStudyIdInfo': {'id': 'RECOND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remote Ischemic per-postconditioning', 'description': 'Remote conditioning is induced by inflation of a blood pressure cuff around the left thigh to 200 mmHg or 20 mmHg above systolic blood pressure (if \\>180 mmHg) for 5 min followed by deflation for 5 min. At least one of these conditioning cycles is performed before PCI is initiated. If time allows, cycles of remote conditioning (5 min leg ischemia and 5 min reperfusion) are repeated until PCI is performed. Following reperfusion, defined as first balloon inflation, four additional cycles of remote conditioning will be performed.', 'interventionNames': ['Procedure: Primary Percutaneous Coronary Intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'The sham procedures include application of the cuff around the thigh but it is not inflated.\n\nOtheriwize normal primary PCI.', 'interventionNames': ['Procedure: Primary Percutaneous Coronary Intervention']}], 'interventions': [{'name': 'Primary Percutaneous Coronary Intervention', 'type': 'PROCEDURE', 'description': 'Primary Percutanous Coronary Intervention is performed in both Groups.', 'armGroupLabels': ['Remote Ischemic per-postconditioning', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyds Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'John Pernow, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Pernow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John Pernow', 'investigatorAffiliation': 'Karolinska Institutet'}}}}