Use of Biomarker Risk Score to Optimize Therapy in Patients With Coronary Artery Disease: The Precision CAD Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 276
- 试验地点
- 10
- 主要终点
- Change in plasma levels of hsCRP
研究概览
简要总结
People with Coronary Artery Disease (CAD) have narrow or blocked arteries that supply blood to the heart. Reduced blood flow to the heart muscle from CAD can cause chest pain or aching, especially with exercise or activity. CAD can lead to weakening of the heart muscle or heart failure, and a higher risk of heart attack or death. Certain proteins in the blood, known as biomarkers, can be found in people with CAD. Higher levels of these biomarkers are associated with a greater risk of complications from CAD. The purpose of this study is to see if a customized treatment based on biomarkers will reduce the biomarker levels and lead to lower risk of complications from CAD.
详细描述
People with Coronary Artery Disease (CAD) have narrow or blocked arteries that supply blood to the heart. Reduced blood flow to the heart muscle from CAD can cause chest pain or aching, especially with exercise or activity. CAD can lead to weakening of the heart muscle or heart failure, and a higher risk of heart attack or death. Certain proteins in the blood, known as biomarkers, can be found in people with CAD. Higher levels of these biomarkers are associated with a greater risk of complications from CAD. The purpose of this study is to see if a customized treatment based on biomarkers will reduce the biomarker levels and lead to lower risk of complications from CAD.
Participants with high biomarker levels will be randomly assigned (like flipping a coin) to either the treatment group or usual care. Both groups will have physical exams, blood tests, and answer questionnaires. Participants in the treatment group will have their medications adjusted based on their biomarker levels. They will also be asked to make lifestyle changes like diet, exercise, and quitting smoking. Participants in the usual care group will receive the standard of care prescribed by their doctor.
This study will take place in research rooms at Emory University Hospital and the Woodruff Memorial Research Building.
Participants will be paid for being in the study.
Participants will be recruited from Emory Healthcare outpatient cardiology clinics and cath labs. Participants will be identified through the medical record and by their doctors. Written consent will be obtained from Participants before they can join the study.
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
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 21-90 years with stable CAD.
- •Patients with any amount of atherosclerosis via coronary angiogram or coronary computed tomography angiography (CCTA).
- •Patients undergoing revascularization therapy or recent acute coronary syndrome (ACS) will be eligible for recruitment and will be recruited at least 4 weeks after admission for an ACS or percutaneous intervention and 3 months after coronary bypass graft surgery.
- •Patients with CAC levels ≥ 400
排除标准
- •Planned revascularization,
- •New York Heart Association class III or IV heart failure symptoms,
- •LVEF <40%,
- •eGFR<45,
- •Pregnancy, congenital heart disease, severe symptomatic valvular heart disease, active malignancy and cardiac transplant.
结局指标
主要结局
Change in plasma levels of hsCRP
时间窗: Baseline, 1 year post intervention
Blood will be drawn for measurement of plasma levels of hsCRP to compare the optimization group and the usual care group.
Change in plasma levels of hs-cTnI
时间窗: Baseline, 1 year post intervention
Blood will be drawn for measurement of plasma levels of hs-cTnI to compare the optimization group and the usual care group.
Change in plasma levels of BNP
时间窗: Baseline, 1 year post intervention
Blood will be drawn for measurement of plasma levels of BNP to compare the optimization group and the usual care group.
Change in plasma levels of suPAR
时间窗: Baseline, 1 year post intervention
Blood will be drawn for measurement of plasma levels of suPAR to compare the optimization group and the usual care group.
Change in Biomarker Risk Score (BRS)
时间窗: Baseline, 1 year post intervention
The BRS score is a simple and manual observation of 4 biomarker results above a predetermined cutpoint that are run on FDA cleared and or CE marked platforms. The BRS is calculated using levels of the 4 biomarkers. Biomarker levels will be considered abnormal if hsCRP is \>3 mg/L, suPAR (pg/mL) \>2863 (males) and \>4063 (women), hs-TnI (pg/mL)\> 6.3 (men), \>5.5 (women), and BNP (pg/mL) \>122 (men), \>184.1 (women). The BRS ranges from 0 to 4 based on the number of biomarkers that are elevated above these cut off values. Higher score correlates with worse outcome.
Change in composite complications
时间窗: Baseline, 1,3,6,9 months post intervention and 1,2,3,5 years post intervention
Difference in rates of composite of CV death/MI/ heart failure hospitalizations, stroke/ revascularization between optimization group, usual care group and registry group.
次要结局
- Change in plasma levels of hsCRP(Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention)
- All cause death(5 years post intervention)
- Change in plasma levels of hs-cTnI(Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention)
- Change in plasma levels of BNP(Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention)
- Change in plasma levels of suPAR(Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention)
研究者
Arshed A. Quyyumi
Professor
Emory University