Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02265250
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Janet Wei, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment
Cardiovascular Disease Atherosclerosis Other: MRI Other: PET/MRI Other: Laboratory blood test

Detailed 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Study Start Date : September 2014
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries

Other: 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

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

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

Other: Laboratory blood test
Cardiovascular biomarkers

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

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

Other: Laboratory blood test
Cardiovascular biomarkers

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

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

Other: Laboratory blood test
Cardiovascular biomarkers




Primary Outcome Measures :
  1. Plaque Volume [ Time Frame: 24 hours ]
    Quantitative plaque measurement using MRI software (VesselMass)

  2. Adverse plaque features [ Time Frame: 24 hours ]
    Presence of positive remodeling, lesion eccentricity, and intraplaque hemorrhage of plaque, on MRI


Secondary Outcome Measures :
  1. 18F-NaF PET uptake [ Time Frame: 3-6 months ]
    Measured as maximum tissue/background ratio (TBR), to assess for high-risk plaque

  2. Laboratory biomarkers [ Time Frame: 24 hours ]
    Measured as levels of LDL-C, HDL-C, lipoprotein(a), ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP

  3. Clinical risk scores [ Time Frame: 24 hours ]
    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


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).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 subjects with known coronary atherosclerosis but varying degrees of CVD risk
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265250


Contacts
Layout table for location contacts
Contact: Denisse Barajas 310-423-9666 denisse.barajas@cshs.org

Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ying Mou, PhD    310-248-7669    ying.mou@cshs.org   
Contact: Sophie Yoo, MS    424-315-4306    Jihye.Yoo@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Janet Wei, MD Cedars-Sinai Medical Center
Principal Investigator: Noel Bairey Merz, MD Cedars-Sinai Medical Center
Layout table for additonal information
Responsible Party: Janet Wei, Co-Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02265250    
Other Study ID Numbers: Pro00037025
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Janet Wei, Cedars-Sinai Medical Center:
magnetic resonance imaging
positron emission tomography
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases