Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atherosclerosis
- Cardiovascular Disease
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
There are up to 2 study visits in this study. During 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. 5 asymptomatic subjects with lower CVD risk (recent coronary arter...
There are up to 2 study visits in this study. During 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. 5 asymptomatic subjects with lower CVD risk (recent coronary artery calcium score [CACS] 10-299) 5 asymptomatic subjects with higher CVD risk (CACS 300-1000) 5 subjects with known coronary atherosclerosis and stable angina 5 subjects with known atherosclerosis and recent acute myocardial infarction The investigators will measure plaque volume and assess adverse plaque features (intra-plaque hemorrhage, positive remodeling, lesion eccentricity) in the three vascular beds. Eight 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. In 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. We 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. All 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.
Tracking Information
- NCT #
- NCT02265250
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Janet Wei, MD Cedars-Sinai Medical Center Principal Investigator: Noel Bairey Merz, MD Cedars-Sinai Medical Center