Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health
研究概览
简要总结
The goal of this randomized controlled trial is to assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health over one year.
详细描述
The main question PROACT 1 aims to answer is whether cardiovascular health improves following disclosure of high polygenic risk result for coronary artery disease compared to standard of care.
This is a 1:1 randomized controlled trial of middle-aged participants with no known cardiovascular disease, are not on lipid-lowering therapy, who have high polygenic risk score for coronary artery disease, and do not have quantifiable plaque on coronary computed tomography angiography. Participants will be randomized into two equal groups: one group will receive their high polygenic risk result for coronary artery disease at baseline, and the other group will receive their result after study completion at 1 year. Change in cardiovascular health as measured by the American Heart Association Life's Essential 8 score from baseline to one-year will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 40 and 75 years of age capable and willing to provide informed consent
- •Participant has high CAD PRS as defined on a clinical test
排除标准
- •Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
- •Participant with quantifiable plaque on a coronary computed tomography angiography
- •Participant with a history of Liver disease (cirrhosis, active hepatitis, or severe hepatic disease) or any of the following recent lab results and determined to be non-transient: alanine aminotransferase greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal (unless due to Gilbert syndrome)
- •Participant with estimated glomerular filtration rate <60 mL/min/1.73 m2 or creatinine greater than 2 times the upper limit of normal
- •Patient with history of an allergic reaction or significant sensitivity to iodinated contrast, colchicine, or statins
- •Patient currently taking LDL cholesterol lowering or anti- inflammatory medications including colchicine
- •Participants requiring regular drugs known to be potent CY2P inhibitors (eg. ketoconazole, clarithromycin)
- •Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study
- •Participant with BMI ≥ 40 kg/m2
- •Participant unable to provide informed consent
- •Participant unable to hold breath for 10 seconds
研究组 & 干预措施
Intervention
Participants will receive their high polygenic risk result for coronary artery disease.
干预措施: Disclosure of high polygenic risk result for coronary artery disease (Behavioral)
Control
Participants will receive standard of care, and disclosure of high polygenic risk result will be deferred until study completion.
结局指标
主要结局
Assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health
时间窗: 1 year
Change in cardiovascular health from baseline to one year as measured by the American Heart Association's Life's Essential 8 (LE8) Score will be compared between an intervention arm that receives a high polygenic risk result for coronary artery disease and a control group that receives standard of care. The LE8 score ranges between 0 and 100 with higher numbers indicating better cardiovascular health.
次要结局
未报告次要终点
研究者
Akl C. Fahed, MD, MPH
Interventional Cardiologist
Massachusetts General Hospital