Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CardioDx
- 入组人数
- 342
- 试验地点
- 7
- 主要终点
- Rate of referral vs. Corus CAD (ASGES) score as continuous variables
研究概览
简要总结
The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.
详细描述
This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.
Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:
- No further cardiac testing or treatment
- Medical therapy for angina or non-cardiac chest pain
- Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.
Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
- •The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
排除标准
- •History of myocardial infarction
- •Current 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
Rate of referral vs. Corus CAD (ASGES) score as continuous variables
时间窗: 30 Days
Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days.
次要结局
- Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores.(30 Day)