Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 2
- 主要终点
- Change in body mass index
研究概览
简要总结
The purpose of this study is to characterize changes in gene and protein expression in peripheral blood in patients with, or at risk for, heart disease during an intensive lifestyle modification program.
详细描述
This project will use an integrated approach that examines DNA variation and the functional products of genes at both the messenger RNA (mRNA) and protein levels to provide a global view of molecular changes associated with drastic lifestyle modifications designed to reverse coronary heart disease (CHD). DNA variants and/or changes in gene and protein expression associated with CHD reversal may provide important clues to understanding molecular mechanisms of subclinical CHD development and progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of coronary artery disease (CAD)
- •stable angina
- •angioplasty
- •evidence of >50% luminal narrowing on coronary angiogram
- •acute myocardial infarction
- •bypass surgery
- •stent placement OR
- •two or more CAD risk factors
- •systolic pressure >140 mm Hg or diastolic pressure >90 mm Hg)
- •high total cholesterol (>200 mg/dL)
- •physician diagnosed diabetes
- •body mass index (BMI) >30
- •family history of heart disease in parents or siblings
- •21 years of age or older
- •mentally competent to provide informed consent
排除标准
- •known history of autoimmune disease
- •systemic/chronic disease requiring chemotherapy or long term treatment
结局指标
主要结局
Change in body mass index
时间窗: Baseline, 12 weeks, 52 weeks
Change in BMI from baseline to 12 weeks and from baseline to 52 weeks
次要结局
- Change in blood pressure(Baseline, 12 weeks, 52 weeks)
- Change in lipids(Baseline, 12 weeks, 52 weeks)
- Change in exercise capacity(Baseline, 12 weeks, 52 weeks)
研究者
Darrell L Ellsworth
Senior Director, Integrative Cardiac Health Program
Windber Research Institute