Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CardioDx
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision
研究概览
简要总结
To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.
详细描述
A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable chest pain, typical or atypical angina or anginal equivalent
- •The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.
排除标准
- •History of myocardial infarction
- •Current myocardial infarct (MI) or acute coronary syndrome
- •Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- •Any previous coronary revascularization
- •Any individuals with:
- •Suspected unstable angina
- •Systemic infections
- •Systemic inflammatory conditions
- •Any individuals currently taking:
- •Immunosuppressive agents
- •Chemotherapeutic agents
- •Recipient of any organ transplant
结局指标
主要结局
Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision
时间窗: Up to 7 days
Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: 1. No further cardiac testing or treatment 2. Medical therapy for angina or non-cardiac chest pain 3. Stress testing with or without imaging 4. CT angiography 5. Invasive cardiac catheterization
Change in management practice pattern between after Corus CAD decision and historical cohort.
时间窗: up to 195 days
Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: 1. No further cardiac testing or treatment 2. Medical therapy for angina or non-cardiac chest pain 3. Stress testing with or without imaging 4. CT angiography 5. Invasive cardiac catheterization
次要结局
未报告次要终点