Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

Cardiovascular Disease Clinical Trial

Official title:

Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02265250
• Other study ID #: Pro00037025
• Status: Recruiting
• Start date: September 2014
• Est. completion date: October 2024

Study information

• Verified date: August 2020
• Source: Cedars-Sinai Medical Center
• Contact: Denisse Barajas
• Phone: 310-423-9666
• Email: denisse.barajas[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• MRI
Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries
• PET/MRI
Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
• Laboratory blood test
Cardiovascular biomarkers

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Volume	Quantitative plaque measurement using MRI software (VesselMass)	24 hours
Primary	Adverse plaque features	Presence of positive remodeling, lesion eccentricity, and intraplaque hemorrhage of plaque, on MRI	24 hours
Secondary	18F-NaF PET uptake	Measured as maximum tissue/background ratio (TBR), to assess for high-risk plaque	3-6 months
Secondary	Laboratory biomarkers	Measured as levels of LDL-C, HDL-C, lipoprotein(a), ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP	24 hours
Secondary	Clinical risk scores	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	24 hours