Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plaque Volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Contraindications to MRI
- •Pregnant and lactating women
- •Body mass index (BMI)>40
- •Active smoking
- •Resting heart rate>75 beats per minute
- •Prior carotid/coronary/peripheral revascularization
- •Life expectancy <5 years
- •Allergy to animal dander
- •Severe asthma
结局指标
主要结局
Plaque Volume
时间窗: 24 hours
Quantitative plaque measurement using MRI software (VesselMass)
Adverse plaque features
时间窗: 24 hours
Presence of positive remodeling, lesion eccentricity, and intraplaque hemorrhage of plaque, on MRI
次要结局
- Laboratory biomarkers(24 hours)
- Clinical risk scores(24 hours)
- 18F-NaF PET uptake(3-6 months)
研究者
Janet Wei
Co-Principal Investigator
Cedars-Sinai Medical Center