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Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

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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

Tracking Information
First Submitted Date October 3, 2014
First Posted Date October 15, 2014
Last Update Posted Date August 10, 2020
Study Start Date September 2014
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 10, 2014)
  • Plaque Volume [ Time Frame: 24 hours ]
    Quantitative plaque measurement using MRI software (VesselMass)
  • Adverse plaque features [ Time Frame: 24 hours ]
    Presence of positive remodeling, lesion eccentricity, and intraplaque hemorrhage of plaque, on MRI
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 10, 2014)
  • 18F-NaF PET uptake [ Time Frame: 3-6 months ]
    Measured as maximum tissue/background ratio (TBR), to assess for high-risk plaque
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Official Title Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
We will obtain fasting lipid and inflammatory biomarkers (LDL-C, HDL-C, lipoprotein(a), ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP).
Sampling Method Non-Probability Sample
Study Population 20 subjects with known coronary atherosclerosis but varying degrees of CVD risk
Condition
  • Cardiovascular Disease
  • Atherosclerosis
Intervention
  • 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
Study Groups/Cohorts
  • 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)

    Interventions:
    • 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

    Interventions:
    • 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

    Interventions:
    • 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

    Interventions:
    • Other: MRI
    • Other: PET/MRI
    • Other: Laboratory blood test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 10, 2014)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Denisse Barajas 310-423-9666 denisse.barajas@cshs.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02265250
Other Study ID Numbers Pro00037025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Janet Wei, Cedars-Sinai Medical Center
Study Sponsor Cedars-Sinai Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Janet Wei, MD Cedars-Sinai Medical Center
Principal Investigator: Noel Bairey Merz, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date August 2020