Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Omic patterns of atherosclerosis
研究概览
简要总结
The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions.
详细描述
The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions. In this protocol, two different forms of imaging will be used to evaluate coronary plaque development (CT coronary angiography) and microvascular function (myocardial contrast echocardiography) to stratify CV risk. Based on this stratification, "omic" patterns (targeted metabolomics, lipidomic, and whole genome sequencing) will be assessed to determine whether there are any patterns that can add to existing predictive models. Outcomes measures will involve correlation of "omic" patterns to incremental risk scaling from lowest (no plaque and normal endothelial function) to highest (+ plaque and endothelial dysfunction).
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
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for clinically indicated CT coronary angiography within 6 months
- •No obstructive coronary plaque and an Agatston score of 0 or At least one obstructive coronary plaque <50% diameter and one other high risk feature on CT-A (positive remodeling, scattered calcification, low Hounsfield units, or "napkin ring" sign.
排除标准
- •Known CAD or other atherosclerotic disease
- •Valvular heart disease (moderate or more) and congenital heart disease
- •Heart failure
- •Pregnancy
- •Allergy to ultrasound contrast agent.
- •Right to left shunt
结局指标
主要结局
Omic patterns of atherosclerosis
时间窗: 2 weeks
In this study, "outcomes" are essentially pre-determined by the patient population according to imaging stratification. Omic patterns of will be assessed by advanced informatics modeling (Random Forest analysis) to determine metabolomic, genomic, and lipidomic patterns that vary according to incremental risk scaling from lowest (no plaque and normal endothelial function) to highest (+ plaque and endothelial dysfunction).
次要结局
未报告次要终点
研究者
Jonathan R. Lindner, MD
Professor
Oregon Health and Science University