Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- CardioDx
- 试验地点
- 9
- 主要终点
- Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group.
研究概览
简要总结
This retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a Corus CAD (Age/Sex/Gene Expression score - ASGES) result compared to patients who did not have the test performed (matched control patients).
详细描述
This retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a Corus CAD (Age/Sex/Gene Expression score - ASGES) result compared to patients who did not have the test performed (matched control patients). The data collected will be from primary care practices and will also assess one to two year health outcomes (MACE, procedure complications). Furthermore, in these real world practice settings, the study will investigate the economic impact of Corus CAD (ASGES) usage at each practice using practice specific data, when available.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •For Corus CAD (Age/Sex/Gene Expression score - ASGES) arm:
- •Symptoms suggestive of obstructive CAD, according to the opinion of the site clinician
- •Age >= 21 years
- •Resulted Corus CAD (ASGES) test used during the evaluation and/or diagnosis of symptoms suggestive of obstructive coronary artery disease (CAD), preferably 1 year prior to data collection date.
- •For Control arm:
- •Symptoms suggestive of obstructive CAD, according to the opinion of the site clinician
- •Eligible for Corus CAD (ASGES) (see exclusion criteria)
- •Matched to Corus CAD (ASGES) patients by sex, age +/-2.5 years, and presenting symptoms
排除标准
- •History of myocardial infarction (MI) or CAD prior to the index evaluation
- •Presentation of high risk unstable angina for the index evaluation
- •Concurrent systemic infection or inflammatory process
- •Concurrent MI or acute coronary syndrome
- •Known diabetes mellitus diagnosis or laboratory test results suggestive of a diagnosis of diabetes mellitus (e.g., HbA1C >=6.5)
- •Use of steroids, immunosuppressive agents, or chemotherapeutic agents, at time of chest pain presentation
结局指标
主要结局
Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group.
时间窗: 120 days
The primary endpoint of the study is the change in number of advanced cardiac diagnostic tests (exercise ECG, stress myocardial perfusion imaging (MPI), cardiac computed tomography angiography (CCTA) or invasive coronary angiography (ICA)) ordered and number of subject referrals to specialty care by the primary clinician, comparing low score Corus CAD (\<=15) patients (Corus CAD arm) and matched control patients who did not receive Corus CAD testing (control arm).
次要结局
- Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects(120 days)