Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00333320
Status:
COMPLETED
Last Update Posted:
2012-10-23
First Post:
2006-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057775', 'term': 'Ischemic Postconditioning'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-22', 'studyFirstSubmitDate': '2006-06-02', 'studyFirstSubmitQcDate': '2006-06-02', 'lastUpdatePostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'coronary reserve after intracoronary adenosine injection', 'timeFrame': 'Immediately after the postconditioning procedure'}], 'secondaryOutcomes': [{'measure': 'frequencies of low reflow and slow reflow situation', 'timeFrame': 'after postconditioning'}, {'measure': 'regression of ST elevation', 'timeFrame': '1h and 24h after postconditioning'}, {'measure': 'left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)', 'timeFrame': 'day 1 and 6'}, {'measure': 'left ventricular systolic function by RMN', 'timeFrame': 'day 8-12'}, {'measure': 'myocardial blush', 'timeFrame': 'after postconditioning'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute myocardial infarction', 'postconditioning', 'coronary reserve', 'ejection fraction'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether brief periods of ischemia performed just at the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and infarct size in humans', 'detailedDescription': 'Desobstruction of the culprit artery after acute myocardial infarction allows to reduce the consequences of prolonged ischemia. However, it is now clearly established that reperfusion induces by itself severe myocardial injuries. Postconditioning has been described as an adaptive response triggered by a brief ischemia applied after a prolonged coronary occlusion. Several teams have reported that ischemia/reperfusion cycles allow to reduce infarct size in experimental models.\n\nDifferent pathophysiological processes have been proposed to explain the beneficial effect of postconditioning. It has been reported that postconditioning reduces the inflammatory response, and activates cardioprotective signaling pathways (Akt, eNOS, p70S6K). In addition, an improvement of the endothelial function has been reported.\n\nThis controlled trial aim to study the potential beneficial effect of postconditioning in patients with acute myocardial infarction. Forty six patients will be included in the study and the culprit artery will be reoccluded three times for 1 minutes after desobstruction in one of the both groups after randomization of the patients.\n\nThe evaluation will be focused on the comparison of the coronary reserve after intracoronary adenosine injection. In addition, additional parameters will be used to study the effect of postconditioning on post-ischemic endothelial dysfunction: frequencies of low reflow and slow reflow situation, myocardial blush and regression of ST elevation. The effect of postconditioning on the left ventricular systolic function will be studied by Doppler tissue imaging and RMN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarction (\\<6 hours)\n* Occlusion of a major coronary vessel\n\nExclusion Criteria:\n\n* History of previous myocardial infarction\n* History of Coronary Artery Bypass Grafting\n* Need for Coronary Artery Bypass Grafting\n* Stenosis not eligible for angioplasty\n* Limited ischemic area\n* Cardiogenic shock\n* Interventricular septum rupture\n* Mitral regurgitation\\>2\n* Ventricular tachycardia\n* Atrioventricular block class II and III'}, 'identificationModule': {'nctId': 'NCT00333320', 'briefTitle': 'Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'POSTCONDITIONING'}, 'secondaryIdInfos': [{'id': 'SFC-2006-02'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '- Control', 'interventionNames': ['Procedure: Control group']}, {'type': 'EXPERIMENTAL', 'label': '-postconditioning group', 'interventionNames': ['Procedure: postconditioning']}], 'interventions': [{'name': 'postconditioning', 'type': 'PROCEDURE', 'description': 'patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion', 'armGroupLabels': ['-postconditioning group']}, {'name': 'Control group', 'type': 'PROCEDURE', 'description': 'Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.', 'armGroupLabels': ['- Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Henri Mondor University Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Philippe Le Corvoisier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henri Mondor University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}