Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT00712894
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2008-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054318', 'term': 'No-Reflow Phenomenon'}], 'ancestors': [{'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004110', 'term': 'Diltiazem'}, {'id': 'D014700', 'term': 'Verapamil'}, {'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009574', 'term': 'Nitro Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2008-07-08', 'studyFirstSubmitQcDate': '2008-07-08', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vessel flow using TIMI flow grade and TIMI frame count', 'timeFrame': 'post-PCI'}], 'secondaryOutcomes': [{'measure': 'major adverse cardiovascular events (MACE)', 'timeFrame': 'within the first 30 days after PCI'}, {'measure': 'Left ventricular ejection fraction (LVEF) through echocardiography', 'timeFrame': 'at 1 and 30 days post-PCI'}, {'measure': 'NT-proBNP levels', 'timeFrame': 'at 1 and 30 days post-PCI'}, {'measure': 'incidence of complete ST-segment resolution', 'timeFrame': '3 hours after PCI'}, {'measure': 'peak troponin T level', 'timeFrame': '24 hours after PCI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute myocardial infarction', 'Percutaneous coronary intervention', 'No-reflow phenomenon', 'Vasodilator agents'], 'conditions': ['Acute Myocardial Infarction', 'Percutaneous Coronary Intervention']}, 'referencesModule': {'references': [{'pmid': '22980307', 'type': 'RESULT', 'citation': 'Huang D, Qian J, Ge L, Jin X, Jin H, Ma J, Liu Z, Zhang F, Dong L, Wang X, Yao K, Ge J. REstoration of COronary flow in patients with no-reflow after primary coronary interVEntion of acute myocaRdial infarction (RECOVER). Am Heart J. 2012 Sep;164(3):394-401. doi: 10.1016/j.ahj.2012.06.015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.', 'detailedDescription': 'No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. This prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of acute myocardial infarction\n* Vessel TIMI flow \\< grade Ⅲ post-PCI\n\nExclusion Criteria:\n\n* Heart failure of New York Heart Association (NYHA) class Ⅲ to class Ⅳ\n* Sick sinus syndrome\n* Atrioventricular block (grade Ⅱ and above)\n* SBP ≤ 90mmHg or cardiogenic shock\n* Heart Rate ≤60 bpm\n* Pregnancy\n* Renal or hepatic failure'}, 'identificationModule': {'nctId': 'NCT00712894', 'acronym': 'EDUCATE-AMI', 'briefTitle': 'Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Reversal of No-reflow/Slow-flow During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction--a Prospective Randomized Study Comparing Intracoronary Infusion of Diltiazem, Verapamil and Nitroglycerin', 'orgStudyIdInfo': {'id': 'Zhongshan 2006-70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of diltiazem via an infusion microcatheter distal to the angioplasty site was performed.', 'interventionNames': ['Drug: Diltiazem']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'V', 'description': 'If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of verapamil via an infusion microcatheter distal to the angioplasty site was performed.', 'interventionNames': ['Drug: Verapamil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N', 'description': 'If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of nitroglycerin via an infusion microcatheter distal to the angioplasty site was performed.', 'interventionNames': ['Drug: Nitroglycerin']}], 'interventions': [{'name': 'Diltiazem', 'type': 'DRUG', 'description': 'Intracoronary Infusion 400-2000ug', 'armGroupLabels': ['D']}, {'name': 'Verapamil', 'type': 'DRUG', 'description': 'Intracoronary Infusion 200-1000ug', 'armGroupLabels': ['V']}, {'name': 'Nitroglycerin', 'type': 'DRUG', 'description': 'Intracoronary Infusion 200-1000ug', 'armGroupLabels': ['N']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Junbo Ge, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cardiology Department', 'investigatorFullName': 'Ge Junbo', 'investigatorAffiliation': 'Fudan University'}}}}