Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 5:41 PM
Study NCT ID:
NCT01986868
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2013-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Adverse Plaque Characteristics by Coronary MR Angiography
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D003287', 'term': 'Contrast Media'}, {'id': 'C064572', 'term': 'gadobenic acid'}, {'id': 'C112666', 'term': 'gadoversetamide'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D064907', 'term': 'Diagnostic Uses of Chemicals'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2013-11-12', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse plaque characteristics present on CMRA', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Magnetic Resonance Angiography', 'CMRA', 'MRI with contrast', 'MultiHance', 'Optimark', 'Gadolinium-based contrast', 'MRA', 'MR angiography'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to determine whether coronary magnetic resonance angiography(CMRA)can identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other substances found in the blood) seen on coronary computed tomography angiography(CCTA) and evaluate whether there is a relationship between the adverse plaque characteristics and the presence of coronary artery wall inflammation.', 'detailedDescription': "This pilot study will examine 20 stable patients who have undergone a clinically-indicated coronary computed tomography angiography (CCTA) for suspected Coronary Artery Disease. They will be invited to undergo a research coronary Magnetic Resonance Imaging scan with contrast(CMRA). Based upon the subject's heart rate, a beta blocker may be administered as its use has been shown to be effective in producing better images as it widens the arteries.\n\nResearchers will use newly developed non-invasive coronary MRA techniques to compare information shown on the research CMRA with the clinical CCTA. While CCTA has been demonstrated to be able to provide data on adverse plaque characteristics (APC's), the ability of CMRA to evaluate these features is not established."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to comprehend and sign informed consent\n* Presence of a non-calcified or mixed plaque without high-grade stenosis in the left main or a proximal coronary artery segment AND at least one APC present in this plaque by CCTA (defined as LAP with \\<30 Hounsfield units or PR with ≥10% increase in the maximal vessel diameter within the plaque as compared to a proximal reference segment as previously described10).\n\nExclusion Criteria:\n\n* High-grade stenosis (≥50% stenosis of the left main artery or ≥70% stenosis of another proximal coronary segment);\n* Coronary artery stent in the segment with the reference plaque\n* Possible pregnancy\n* Glomerular filtration rate \\<45 ml/min\n* More than 90 days between CCTA and CMRA study\n* Any significant arrhythmia (e.g. atrial fibrillation, frequent ectopy)\n* Significant asthma\n* History of 2nd or 3rd degree heart block\n* Allergy or known intolerance to beta-blockers\n* Use of phosphodiesterase inhibitor (e.g. Viagra) within the last 48 hours\n* Rapid heart rate (heart rate ≥90 beats/minute)\n* Severe aortic stenosis (Aortic valve area \\<1.0 cm2 or mean gradient \\>30 mmHg)\n* Systolic blood pressure \\<100 mmHg\n* Other contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia'}, 'identificationModule': {'nctId': 'NCT01986868', 'briefTitle': 'Identification of Adverse Plaque Characteristics by Coronary MR Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Identification of Adverse Plaque Characteristics by Coronary Magnetic Resonance Angiography', 'orgStudyIdInfo': {'id': '27850'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Coronary MR Angiography (CMRA)', 'description': 'Coronary MR Angiography(CMRA). A gadolinium-based contrast (Optimark or MultiHance) will be administered as well as a beta blocker which will be assigned based upon heart rate.', 'interventionNames': ['Other: Coronary MR Angiography (CMRA)']}], 'interventions': [{'name': 'Coronary MR Angiography (CMRA)', 'type': 'OTHER', 'otherNames': ['MRI with contrast', 'MultiHance', 'Optimark', 'Gadolinium-based contrast', 'MRA', 'MR Imaging', 'MR angiography'], 'description': 'Stable patients who have undergone a clinically indicated CCTA study for suspected Coronary Artery Disease will undergo a research CMRA with contrast (Multihance or Optimark)total dose of up to 0.2 mmol/kg IV. Possible administration of oral beta-blocker (metoprolol)intravenous doses of 5mg IV metoprolol may be given every 2 minutes up to a maximal dose of 15 mg IV.', 'armGroupLabels': ['Coronary MR Angiography (CMRA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Daniel S Berman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daniel S. Berman', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}