Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-08 @ 3:01 PM
Study NCT ID:
NCT00493168
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2007-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of the Prevalence and Prognostic Importance of Unrecognized Non-Q-wave Myocardial Infarction by MRI
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-24', 'studyFirstSubmitDate': '2007-06-26', 'studyFirstSubmitQcDate': '2007-06-26', 'lastUpdatePostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-28', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Coronary Arteriosclerosis', 'Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '19381280', 'type': 'DERIVED', 'citation': 'Kim HW, Klem I, Shah DJ, Wu E, Meyers SN, Parker MA, Crowley AL, Bonow RO, Judd RM, Kim RJ. Unrecognized non-Q-wave myocardial infarction: prevalence and prognostic significance in patients with suspected coronary disease. PLoS Med. 2009 Apr 21;6(4):e1000057. doi: 10.1371/journal.pmed.1000057. Epub 2009 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'The first aim of this study is to determine how often unrecognized myocardial infarction occur in patients using a magnetic resonance imaging (MRI) technique (known as delayed enhancement MRI), as compared to the electrocardiogram. The second aim of this study is to determine the severity of coronary heart disease of the patients with unrecognized myocardial infarction. The final aim is to determine how the presence of unrecognized myocardial infarction detected by the MRI affects lifespan.', 'detailedDescription': 'Unrecognized myocardial infarction (MI) is known to constitute a substantial portion of lethal coronary heart disease. However, since the diagnosis of unrecognized MI is based on the appearance of incidental Q-waves on 12-lead electrocardiography, the syndrome of unrecognized non-Q-wave MI has not been described. Delayed-enhancement cardiovascular magnetic resonance (DE-CMR) can accurately identify non-Q-wave MI. The aims of this study are three-fold: 1. to determine the prevalence of unrecognized non-Q-wave and Q-wave MI, 2. to define predictors of unrecognized non-Q-wave MI, 3. to determine the prognostic significance of unrecognized non-Q-wave MI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected coronary artery disease referred for invasive coronary angiography\n\nExclusion Criteria:\n\n* Clinical history of myocardial infarction\n* Percutaneous coronary intervention\n* Coronary artery bypass surgery\n* Known uncured malignancy\n* History of hypertrophic cardiomyopathy, myocarditis, or infiltrative heart disease\n* Contraindication of magnetic resonance imaging'}, 'identificationModule': {'nctId': 'NCT00493168', 'briefTitle': 'Determination of the Prevalence and Prognostic Importance of Unrecognized Non-Q-wave Myocardial Infarction by MRI', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Unrecognized Non-Q-wave Myocardial Infarction: Prevalence, Angiographic Correlation, and Prognostic Significance in Patients With Suspected Coronary Disease', 'orgStudyIdInfo': {'id': '3434'}}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Medical School', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cardiovascular Magnetic Resonance Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Han W Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Cardiovascular Magnetic Resonance Center'}, {'name': 'Raymond J Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Cardiovascular Magnetic Resonance Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}