Recruiting

Observational Study

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT02265250

Conditions

Cardiovascular Disease

Atherosclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI

PET/MRI

Laboratory blood test

Study Details

Brief 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.

Conditions

Cardiovascular Disease

Atherosclerosis

Study ID

NCT02265250

Start date

Sep, 2014

Status verified date

Aug, 2020

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Asymptomatic, CACS <300

5 asymptomatic subjects with low CVD risk, defined as recent coronary artery calcium score (CACS) <300

Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers)

Asymptomatic, CACS ≥300

5 asymptomatic subjects with increased CVD risk, defined as a recent coronary artery calcium score (CACS) ≥300

Noncontrast 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

Stable angina

5 subjects with stable angina and evidence of coronary atherosclerosis based on a recent invasive or CT coronary angiogram

Noncontrast 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

Recent acute MI

5 subjects with a recent acute myocardial infarction (within 1 month) and evidence of coronary atherosclerosis based on invasive or CT coronary angiogram

Noncontrast 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

Interventions

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

Primary outcome measure

  • Plaque Volume [ Time Frame: 24 hours ]
  • Adverse plaque features [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Denisse Barajas

310-423-9666denisse.barajas@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Ying Mou, PhD

310-248-7669ying.mou@cshs.org

Sophie Yoo, MS

424-315-4306Jihye.Yoo@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Aug 10, 2020

Last verified

Aug, 2020

Keywords

  • magnetic resonance imaging
  • positron emission tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2020-08-10.