Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-21 @ 1:51 AM
Study NCT ID:
NCT00661232
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2008-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Myocardial Viability Trial
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2011-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2008-04-16', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine whether the extent of irreversible myocardial injury as assessed by Delayed Enhancement Magnetic Resonance Imaging can predict the extent of functional recovery after revascularization in patients with chronic coronary artery disease (CAD).', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myocardial Viability', 'Delayed Enhancement Magnetic Resonance Imaging', 'Functional Recovery'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic Resonance Imaging can be used to predict improvement of the wall motion in regions of the heart with abnormal movement following bypass surgery or percutaneous angioplasty in various institutions across three continents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were recruited from 9 institutions on 3 different continent. All patients recruited for the study had a history of angiographically documented chronic coronary artery disease and resting wall motion abnormalities, and were scheduled for cardiac revascularization (coronary artery bypass surgery or percutaneous intervention).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: \\> 21 years and \\< 85 years\n* Sinus rhythm\n* Weight \\< 120 kg\n* LVEF \\> 30%\n* Wall motion abnormality on Echo. or LV-gram\n* Scheduled for revascularization - Angioplasty/Stent or CABG - within 30 days\n\nExclusion Criteria:\n\n* Resting heart rate \\> 100 bpm\n* Frequent atrial or ventricular ectopy\n* Severe aortic stenosis or HOCM\n* Unstable angina\n* Myocardial infarction within 14 days\n* Active congestive heart failure\n* Pregnancy\n* Known allergy to gadolinium\n* Contraindication to MRI'}, 'identificationModule': {'nctId': 'NCT00661232', 'briefTitle': 'Multicenter Myocardial Viability Trial', 'organization': {'class': 'OTHER', 'fullName': "CHI St. Luke's Health, Texas"}, 'officialTitle': 'An International, Multicenter Trial Assessing Myocardial Viability With Contrast - Enhanced Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': '1102-02-777'}, 'secondaryIdInfos': [{'id': 'NDA# 20-937'}, {'id': 'IND# 66,506'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Episcopal Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Episcopal Location", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'B-1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires St. Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Skejby University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '15123', 'city': 'Marousi', 'country': 'Greece', 'facility': 'Hygeia Hospital', 'geoPoint': {'lat': 38.05, 'lon': 23.8}}, {'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital'}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Cardiac MRI Unit', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Scott D Flamm, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CHI St. Luke's Health, Texas"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "CHI St. Luke's Health, Texas", 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Scott D. Flamm, M.D.', 'investigatorAffiliation': "CHI St. Luke's Health, Texas"}}}}