Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-22 @ 9:35 AM
Study NCT ID:
NCT02265250
Status:
UNKNOWN
Last Update Posted:
2020-08-10
First Post:
2014-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'We will obtain fasting lipid and inflammatory biomarkers (LDL-C, HDL-C, lipoprotein(a), ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque Volume', 'timeFrame': '24 hours', 'description': 'Quantitative plaque measurement using MRI software (VesselMass)'}, {'measure': 'Adverse plaque features', 'timeFrame': '24 hours', 'description': 'Presence of positive remodeling, lesion eccentricity, and intraplaque hemorrhage of plaque, on MRI'}], 'secondaryOutcomes': [{'measure': '18F-NaF PET uptake', 'timeFrame': '3-6 months', 'description': 'Measured as maximum tissue/background ratio (TBR), to assess for high-risk plaque'}, {'measure': 'Laboratory biomarkers', 'timeFrame': '24 hours', 'description': 'Measured as levels of LDL-C, HDL-C, lipoprotein(a), ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP'}, {'measure': 'Clinical risk scores', 'timeFrame': '24 hours', 'description': 'Measured as (1) ACC/AHA 10-year and lifetime atherosclerotic CVD risk, (2) Framingham 10-year CVD risk, and (3) Reynolds Risk 10-year CVD risk'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['magnetic resonance imaging', 'positron emission tomography'], 'conditions': ['Cardiovascular Disease', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'Cardiovascular disease (CVD) remains the leading cause of death in the United States, and improved CVD risk assessment is needed for personalized medicine. Atherosclerosis measures including plaque volume and adverse plaque features have prognostic value. Novel techniques have been developed for assessing carotid, coronary, and femoral atherosclerosis using magnetic resonance imaging (MRI) methods that are rapid and reproducible, have improved spatial resolution, and do not require contrast media, making atherosclerosis assessment in multiple vascular beds feasible during a single MRI session. This pilot research will provide preliminary data to develop an innovative global atherosclerosis measure including carotid, coronary, and femoral vascular beds, for assessing cardiovascular risk and for monitoring atherosclerosis response to therapy. 20 participants will be recruited in one year.', 'detailedDescription': 'There are up to 2 study visits in this study.\n\nDuring the first visit, the investigators will obtain non-contrast MRI (carotid, coronary, and femoral) in 20 subjects with known coronary atherosclerosis but varying degrees of CVD risk.\n\n1. 5 asymptomatic subjects with lower CVD risk (recent coronary artery calcium score \\[CACS\\] 10-299)\n2. 5 asymptomatic subjects with higher CVD risk (CACS 300-1000)\n3. 5 subjects with known coronary atherosclerosis and stable angina\n4. 5 subjects with known atherosclerosis and recent acute myocardial infarction\n\nThe investigators will measure plaque volume and assess adverse plaque features (intra-plaque hemorrhage, positive remodeling, lesion eccentricity) in the three vascular beds.\n\nEight of these subjects with evidence of large plaque burden by MRI will be asked to return for a simultaneous positron emission tomography (PET)-MRI imaging with 18F-sodium fluoride (18F-NaF) of their carotid, coronary, and femoral arteries, in which 18F-NaF uptake in plaque will represent micro-calcifications, which is associated with high-risk plaque.\n\nIn all 20 subjects, the investigators will also measure the following biomarkers which have been shown to be useful for CVD risk assessment of atherosclerosis: LDL, HDL, lipoprotein(a), apolipoprotein B/A-1 ratio, hemoglobin A1c, adiponectin, and highly sensitive C-reactive protein. The investigators will also calculate their estimated 10-year and lifetime atherosclerotic CVD risk (American Heart Association), Framingham 10-year CVD risk, and Reynolds 10-year CVD risk scores.\n\nWe aim to obtain the second scan within 3 months of the first visit; thus, the subjects will participate in the study for approximately 3 months.\n\nAll the procedures are research-related. The research visit will take approximately 3 hours, and there will be maximum two visits. There are no collaborations with other sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20 subjects with known coronary atherosclerosis but varying degrees of CVD risk', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women with evidence of coronary atherosclerosis based on a recent CACS 10-1000 or an invasive or CT coronary angiogram (within 6 weeks of recruitment)\n2. No planned revascularization procedures\n\nExclusion Criteria:\n\n1. Contraindications to MRI\n2. Pregnant and lactating women\n3. Body mass index (BMI)\\>40\n4. Active smoking\n5. Resting heart rate\\>75 beats per minute\n6. Arrhythmia\n7. Prior carotid/coronary/peripheral revascularization\n8. Life expectancy \\<5 years\n9. Allergy to animal dander\n10. Severe asthma'}, 'identificationModule': {'nctId': 'NCT02265250', 'briefTitle': 'Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment', 'orgStudyIdInfo': {'id': 'Pro00037025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asymptomatic, CACS <300', 'description': '5 asymptomatic subjects with low CVD risk, defined as recent coronary artery calcium score (CACS) \\<300\n\nNoncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers)', 'interventionNames': ['Other: MRI', 'Other: Laboratory blood test']}, {'label': 'Asymptomatic, CACS ≥300', 'description': '5 asymptomatic subjects with increased CVD risk, defined as a recent coronary artery calcium score (CACS) ≥300\n\nNoncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries', 'interventionNames': ['Other: MRI', 'Other: PET/MRI', 'Other: Laboratory blood test']}, {'label': 'Stable angina', 'description': '5 subjects with stable angina and evidence of coronary atherosclerosis based on a recent invasive or CT coronary angiogram\n\nNoncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries', 'interventionNames': ['Other: MRI', 'Other: PET/MRI', 'Other: Laboratory blood test']}, {'label': 'Recent acute MI', 'description': '5 subjects with a recent acute myocardial infarction (within 1 month) and evidence of coronary atherosclerosis based on invasive or CT coronary angiogram\n\nNoncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries', 'interventionNames': ['Other: MRI', 'Other: PET/MRI', 'Other: Laboratory blood test']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'description': 'Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries', 'armGroupLabels': ['Asymptomatic, CACS <300', 'Asymptomatic, CACS ≥300', 'Recent acute MI', 'Stable angina']}, {'name': 'PET/MRI', 'type': 'OTHER', 'description': 'Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries', 'armGroupLabels': ['Asymptomatic, CACS ≥300', 'Recent acute MI', 'Stable angina']}, {'name': 'Laboratory blood test', 'type': 'OTHER', 'description': 'Cardiovascular biomarkers', 'armGroupLabels': ['Asymptomatic, CACS <300', 'Asymptomatic, CACS ≥300', 'Recent acute MI', 'Stable angina']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ying Mou, PhD', 'role': 'CONTACT', 'email': 'ying.mou@cshs.org', 'phone': '310-248-7669'}, {'name': 'Sophie Yoo, MS', 'role': 'CONTACT', 'email': 'Jihye.Yoo@cshs.org', 'phone': '424-315-4306'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Denisse Barajas', 'role': 'CONTACT', 'email': 'denisse.barajas@cshs.org', 'phone': '310-423-9666'}], 'overallOfficials': [{'name': 'Janet Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}, {'name': 'Noel Bairey Merz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Janet Wei', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}