Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- To determine the proportion of subjects and patients who are diagnosed with subclinical and clinically significant coronary atherosclerosis with the PHI-ACE-iCARE approach, compared to the current guideline-driven approach.
研究概览
简要总结
This study will evaluate the effectiveness of an individualized approach to diagnosing and/or treating atherosclerosis. This will be done by combining genetic information, lifestyle information, participant education, and imaging tests to track diagnoses, therapies, and treatment on two groups: 1) Standard Management Group (diagnosed and/or treated according to standard of care) and 2) Individualized Management Group (standard of care plus genetic testing and coronary artery calcium scans).
详细描述
The purpose of this proposal is to create a large, community-based demonstration project to evaluate the value of a highly individualized approach to atherosclerosis risk reduction. In this project we set out to compare the delivery of appropriate therapies and resource utilization using current national guidelines for the management of atherosclerosis and will compare this to using a highly individualized approach for atherosclerosis risk reduction, based on the evaluation of specific features in individuals and tailoring management based on this evaluation. We plan to show that utilizing the iCARE Program, more patients will receive appropriate diagnoses and subsequent therapies in a more efficient manner.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •No known coronary artery disease
- •no prior coronary disease by cardiac catheterization (≤39% in any major epicardial vessel)
- •no prior myocardial infarction
- •no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads)
- •no prior non-ST-elevation myocardial infarction (CK-MB > 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints)
- •no prior coronary revascularization procedure
- •Intermediate or high Framingham Risk Score (10-year risk 10% or greater)
- •Ability and willingness to provide consent and Authorization for use of PHI
排除标准
- •Presence of known cardiomyopathy
- •Presence of permanent pacemaker, defibrillator, or CRT device
- •Presence of clinically significant, uncontrolled arrhythmia (chronic or paroxysmal atrial fibrillation is NOT an exclusion. Arrhythmias treated successfully with ablation are not an exclusion.
- •Presence of a known genetic abnormality of cholesterol metabolism (e.g. familial hypercholesterolemia)
- •Inability or unwillingness to adhere to follow up schedule
- •Inability or unwillingness to provide informed consent and Authorization for use of PHI
结局指标
主要结局
To determine the proportion of subjects and patients who are diagnosed with subclinical and clinically significant coronary atherosclerosis with the PHI-ACE-iCARE approach, compared to the current guideline-driven approach.
时间窗: 6 months, 12 months, 18 months
次要结局
- To determine the proportion of patients who receive appropriate revascularization procedures for clinically significant coronary atherosclerosis with the PHI-ACE-iCARE approach, compared to the current guideline-driven approach.(6 month, 12 months, 18 months)