The PRESET Registry: A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Real World Clinical Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CardioDx
- 入组人数
- 713
- 试验地点
- 13
- 主要终点
- To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.
研究概览
简要总结
The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings (PRESET)--was designed as an observational, post-market, real-world registry to evaluate patterns of care, including referrals to a cardiologist, cardiac stress testing, CT angiography, within the first month after Corus CAD (ASGES) testing.
详细描述
The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients presenting with typical or atypical symptoms suggestive of obstructive coronary artery disease from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and Corus CAD (Age/Sex/Gene Expression score - ASGES) results (predefined as low [ASGES <15] or elevated [ASGES >15]) were collected, as were referrals to Cardiology or further functional/anatomic cardiac testing after Corus CAD (Age/Sex/Gene Expression score - ASGES) testing. Patients were followed for 1 year post ASGES testing.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms suggestive of CAD, according to the opinion of the site registry clinician
- •Receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD
- •Age >= 18 years
- •Willing and able to provide written informed consent
排除标准
- •History of myocardial infarction (MI)
- •Current MI or acute coronary syndrome
- •Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- •Known/documented CAD
- •Diabetes Mellitus
结局指标
主要结局
To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.
时间窗: 1 month
次要结局
- To describe follow up events (eg., diagnoses, non-cardiac testing, medication use, MACE) at 12 months follow up within ASGES (age, sex,gene expression score) test strata.(12 months)