Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

NCT02265250 | Unknown DMC

• 1 other identifier: Pro00037025
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

magnetic resonance imaging; positron emission tomography

Outcome Measures

Primary Outcomes (2)

• Plaque Volume

  Quantitative plaque measurement using MRI software (VesselMass)

  24 hours

• Adverse plaque features

  Presence of positive remodeling, lesion eccentricity, and intraplaque hemorrhage of plaque, on MRI

  24 hours

Secondary Outcomes (3)

• 18F-NaF PET uptake

  3-6 months

• Laboratory biomarkers

  24 hours

• Clinical risk scores

  24 hours

Study Arms (4)

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)

Other: MRI; Other: Laboratory blood test

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

Other: MRI; Other: PET/MRI; Other: Laboratory blood test

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

Other: MRI; Other: PET/MRI; Other: Laboratory blood test

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

Other: MRI; Other: PET/MRI; Other: Laboratory blood test

Interventions

MRI OTHER

Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries

Asymptomatic, CACS <300; Asymptomatic, CACS ≥300; Recent acute MI; Stable angina

PET/MRI OTHER

Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries

Asymptomatic, CACS ≥300; Recent acute MI; Stable angina

Laboratory blood test OTHER

Cardiovascular biomarkers

Asymptomatic, CACS <300; Asymptomatic, CACS ≥300; Recent acute MI; Stable angina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 subjects with known coronary atherosclerosis but varying degrees of CVD risk

You may qualify if:

• 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)
• No planned revascularization procedures

You may not qualify if:

• Contraindications to MRI
• Pregnant and lactating women
• Body mass index (BMI)\>40
• Active smoking
• Resting heart rate\>75 beats per minute
• Arrhythmia
• Prior carotid/coronary/peripheral revascularization
• Life expectancy \<5 years
• Allergy to animal dander
• Severe asthma

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will obtain fasting lipid and inflammatory biomarkers (LDL-C, HDL-C, lipoprotein(a), ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP).

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Janet Wei, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Noel Bairey Merz, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denisse Barajas

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)