Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/14/2018 |
| Start Date: | September 2014 |
| End Date: | October 2018 |
| Contact: | Ying Mou, PhD |
| Email: | ying.mou@cshs.org |
| Phone: | 310-248-7669 |
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.
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.
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.
1. 5 asymptomatic subjects with lower CVD risk (recent coronary artery calcium score [CACS]
10-299)
2. 5 asymptomatic subjects with higher CVD risk (CACS 300-1000)
3. 5 subjects with known coronary atherosclerosis and stable angina
4. 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.
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.
1. 5 asymptomatic subjects with lower CVD risk (recent coronary artery calcium score [CACS]
10-299)
2. 5 asymptomatic subjects with higher CVD risk (CACS 300-1000)
3. 5 subjects with known coronary atherosclerosis and stable angina
4. 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.
Inclusion Criteria:
1. 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)
2. No planned revascularization procedures
Exclusion Criteria:
1. Contraindications to MRI
2. Pregnant and lactating women
3. Body mass index (BMI)>40
4. Active smoking
5. Resting heart rate>75 beats per minute
6. Arrhythmia
7. Prior carotid/coronary/peripheral revascularization
8. Life expectancy <5 years
9. Allergy to animal dander
10. Severe asthma
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-248-7669
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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