Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT00353795
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2006-07-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bluemked@nih.gov', 'phone': '301 402 1854', 'title': 'David Bluemke', 'organization': 'NIH'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Cross sectional study'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Participants', 'description': 'Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008', 'otherNumAtRisk': 179, 'otherNumAffected': 0, 'seriousNumAtRisk': 179, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Coronary Wall Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants', 'description': 'Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'n/a (cross sectional analysis)', 'description': 'Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants', 'description': 'Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants', 'description': 'Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '179', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-25', 'studyFirstSubmitDate': '2006-07-18', 'resultsFirstSubmitDate': '2009-08-04', 'studyFirstSubmitQcDate': '2006-07-18', 'lastUpdatePostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-05-25', 'studyFirstPostDateStruct': {'date': '2006-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Coronary Wall Thickness', 'timeFrame': 'n/a (cross sectional analysis)', 'description': 'Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).'}]}, 'conditionsModule': {'keywords': ['MESA', 'MRI', 'Cardiovascular', 'Cardiac', 'Coronary', 'Atherosclerosis'], 'conditions': ['Coronary Arteriosclerosis', 'Arteriosclerosis, Coronary', 'Atherosclerosis, Coronary', 'Coronary Artery Disease', 'Coronary Atherosclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mesa-nhlbi.org/', 'label': 'Multi-Ethnic Study of Atherosclerosis webpage'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this study is to use MRI to:\n\n* Examine the relationship between known risk factors for cardiovascular disease and coronary artery wall thickness;\n* Examine the relationship between coronary artery wall thickness and other markers of subclinical coronary atherosclerosis, such as carotid wall thickness and coronary calcium scores; and,\n* Examine the feasibility of measuring the progression of coronary artery wall thickness over time in a subset of participants.', 'detailedDescription': 'Each enrolled participant will undergo MR Imaging of the coronary arteries in conjunction with their routine MESA follow-up visit. The MRI will last approximately 45-60 minutes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior enrollment in the MESA Study at the Hopkins MESA Field Center or the Northwestern University MESA Field Center\n* Male or Female adult equal to or older than 45 years of age\n* Willing/able to provide informed consent\n\nExclusion Criteria:\n\n* Any known contraindications to MRI (i.e. severe claustrophobia, pacemaker, etc.)\n* Metal in the eyes'}, 'identificationModule': {'nctId': 'NCT00353795', 'briefTitle': 'Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Coronary Atherosclerosis Evaluation by Arterial Wall MRI', 'orgStudyIdInfo': {'id': '05-05-23-01'}, 'secondaryIdInfos': [{'id': '5R01HL078909', 'link': 'https://reporter.nih.gov/quickSearch/5R01HL078909', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MR Imaging of the Coronary Arteries', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University MESA Field Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21244', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins MESA Field Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'David A Bluemke, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}]}}}