Cardiovascular DiseaseNCT02265250
Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
An observational study of Cardiovascular Disease and Atherosclerosis, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Atherosclerosis
- What is being tested?
- MRI, PET/MRI and Laboratory blood test
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 subjects with known coronary atherosclerosis but varying degrees of CVD risk
Who may be able to join
- 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
Who cannot join
- Contraindications to MRI
- Pregnant and lactating women
- Body mass index (BMI)>40
- Active smoking
- Resting heart rate>75 beats per minute
- Arrhythmia
Show all 10Show fewer
- Prior carotid/coronary/peripheral revascularization
- Life expectancy <5 years
- Allergy to animal dander
- Severe asthma
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Ying Mou, PhD, 310-248-7669, ying.mou@cshs.org
Sophie Yoo, MS, 424-315-4306, Jihye.Yoo@cshs.org
About this study
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.
Read the 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.
- 5 asymptomatic subjects with lower CVD risk (recent coronary artery calcium score [CACS] 10-299)
- 5 asymptomatic subjects with higher CVD risk (CACS 300-1000)
- 5 subjects with known coronary atherosclerosis and stable angina
- 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.
- Conditions
- Cardiovascular Disease, Atherosclerosis
- Being tested
- MRI, PET/MRI, Laboratory blood test
- Keywords
- magnetic resonance imaging, positron emission tomography
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries
PET/MRIOther
Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
Laboratory blood testOther
Cardiovascular biomarkers
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: 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 Receives: 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 Receives: Other: MRI; Other: PET/MRI; Other: Laboratory blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Volume
Quantitative plaque measurement using MRI software (VesselMass)
Measured: 24 hours
Adverse plaque features
Presence of positive remodeling, lesion eccentricity, and intraplaque hemorrhage of plaque, on MRI
Measured: 24 hours
Secondary outcomes (3)
18F-NaF PET uptake
Measured as maximum tissue/background ratio (TBR), to assess for high-risk plaque
Measured: 3-6 months
Laboratory biomarkers
Measured as levels of LDL-C, HDL-C, lipoprotein(a), ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP
Measured: 24 hours
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Wei, Cedars-Sinai Medical Center
- Investigators
- Janet Wei, MD, Principal investigator, Cedars-Sinai Medical CenterNoel Bairey Merz, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265250
- Sponsor's protocol ID
- Pro00037025
- Status last verified
- Aug 2020
- First submitted
- 3 Oct 2014
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
- ClinicalTrials.gov ID
- NCT02265250
- Acronym / sponsor ID
- Pro00037025
- Conditions
- Cardiovascular Disease, Atherosclerosis
- Keywords
- magnetic resonance imaging, positron emission tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 5 asymptomatic subjects with lower CVD risk (recent coronary artery calcium score [CACS] 10-299)
- 5 asymptomatic subjects with higher CVD risk (CACS 300-1000)
- 5 subjects with known coronary atherosclerosis and stable angina
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic, CACS <300 | – | Other: MRI, Other: Laboratory blood test5 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 | – | Other: MRI, Other: PET/MRI, Other: Laboratory blood test5 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 | – | Other: MRI, Other: PET/MRI, Other: Laboratory blood test5 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 | – | Other: MRI, Other: PET/MRI, Other: Laboratory blood test5 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 subjects with known coronary atherosclerosis but varying degrees of CVD risk
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- Contraindications to MRI
- Pregnant and lactating women
- Body mass index (BMI)>40
- Active smoking
- Resting heart rate>75 beats per minute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRINoncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries | Other | Asymptomatic, CACS <300, Asymptomatic, CACS ≥300, Recent acute MI, Stable angina |
| PET/MRISimultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries | Other | Asymptomatic, CACS ≥300, Recent acute MI, Stable angina |
| Laboratory blood testCardiovascular biomarkers | Other | Asymptomatic, CACS <300, Asymptomatic, CACS ≥300, Recent acute MI, Stable angina |
Primary outcome
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
3 secondary outcomes
18F-NaF PET uptake
Time frame: 3-6 months
Laboratory biomarkers
Time frame: 24 hours
Clinical risk scores
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Wei, MD principal investigator
Cedars-Sinai Medical Center
Noel Bairey Merz, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Atherosclerosis, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denisse Barajas (310-423-9666, denisse.barajas@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Volume (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.