Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-02 @ 3:15 AM
Study NCT ID:
NCT00456950
Status:
COMPLETED
Last Update Posted:
2009-09-24
First Post:
2007-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging of the Coronary Vessel Wall
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': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2009-09-23', 'studyFirstSubmitDate': '2007-04-04', 'studyFirstSubmitQcDate': '2007-04-04', 'lastUpdatePostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary atherosclerosis', 'magnetic resonance imaging', 'vulnerable plaque'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '20927368', 'type': 'DERIVED', 'citation': 'Gerretsen SC, Kooi ME, Kessels AG, Schalla S, Katoh M, van der Geest RJ, Manning WJ, Waltenberger J, van Engelshoven JM, Botnar RM, Leiner T. Visualization of coronary wall atherosclerosis in asymptomatic subjects and patients with coronary artery disease using magnetic resonance imaging. PLoS One. 2010 Sep 29;5(9):e12998. doi: 10.1371/journal.pone.0012998.'}]}, 'descriptionModule': {'briefSummary': 'Despite advances in prevention and treatment, clinical manifestations of atherosclerosis (e.g. myocardial infarction, stroke) remain the largest cause of mortality in the Western world. The occurrence of acute ischemic syndromes, including unstable angina and myocardial infarction, is highly associated with atherosclerotic plaque morphology.\n\nMagnetic resonance (MR) imaging is able to noninvasively depict the lumen of coronary arteries without the need for ionizing radiation. In addition, MR imaging is able to generate soft-tissue contrast unlike any other imaging modality. It has been shown in the aorta and carotid artery that MR imaging is able to identify different atherosclerotic plaque components in vivo. Similar MR imaging techniques are becoming available to visualize the coronary arterial wall and preliminary studies have shown the feasibility of MR coronary vessel wall imaging in humans.\n\nThe overall aim of the current study is to identify in vivo MR coronary vessel wall and plaque features that are associated with acute coronary syndromes. This study is divided into 2 substudies:\n\n1. Detection of atherosclerosis in the coronary vessel wall with contrast-enhanced MR imaging in patients with coronary artery disease and age-matched healthy volunteers.\n2. Characterization of coronary vessel wall plaque morphology in patients with stable and unstable angina: validation of MRI with the current standard of reference intravascular ultrasound (IVUS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Patients with (un)stable angina or non-st-elevated myocardial infarction: sample from dept. of cardiology\n* healthy volunteers: community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with (un)stable angina or non-ST-elevated myocardial infarction\n* patients are scheduled for, or recently had X-ray coronary angiography\n* healthy volunteers, no clinical history of coronary artery disease(control group for substudy 1)\n* patients with non-ischemic heart disease, scheduled for X-ray coronary angiography (control group for substudy 2)\n* informed consent\n\nExclusion Criteria:\n\n* severe arrhythmia\n* hemodynamic unstable patients\n* contra-indications for MRI'}, 'identificationModule': {'nctId': 'NCT00456950', 'briefTitle': 'Magnetic Resonance Imaging of the Coronary Vessel Wall', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Detection of Vulnerable Plaque With Coronary Vessel Wall Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'MEC 04-272'}}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Tim Leiner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'T. Leiner, M.D., PhD', 'oldOrganization': 'Dept. of Radiology, Maastricht University Hospital'}}}}