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临床试验/NCT01594411
NCT01594411已完成不适用

Investigation of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Primary Care Practice Pattern

CardioDx4 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CardioDx
入组人数
251
试验地点
4
主要终点
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score

研究概览

简要总结

This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.

详细描述

In symptomatic patients with or without prior cardiac testing, the PCP will initially decide the subject's pretest probability for coronary artery disease (CAD) based on the subject's risk factors and quality of chest pain (typical or atypical), or anginal equivalent (e.g., jaw, arm pain, or unexplained shortness of breath) and consider the results of prior testing, if applicable. The initial questionnaire will capture the PCP's initial clinical impression and decision ('preliminary decision') on how to further evaluate and manage the patient. A Corus CAD (Age/Sex/Gene Expression score - ASGES) assay will be performed at the PCP's office. After the PCP has received the Corus CAD (ASGES) result (approximately 2-3 days later), the PCP will decide on the appropriate evaluation and management of the patient ('final decision') using the Corus CAD (ASGES) result in conjunction with his/her clinical impression and/or other clinical data available. The primary aim of this study is to evaluate whether the Corus CAD (ASGES) test results is associated with a change in the PCPs' diagnostic evaluation and management of patients as compared to their initial testing and treatment decisions.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (ASGES), symptomatic subjects with unstable angina, or suspicion for myocardial infarction will be excluded from the study.

A follow-up phone call and a detailed questionnaire will be performed at 30 + 15 days, from the time of blood draw, to assess the triage decision, such as referral to any subspecialists (cardiologist, gastroenterologist, and pulmonologist), cardiac diagnostic tests performed, cardiac procedures performed, and results of these cardiac tests and procedures.

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

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 infarction (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
  • Any Major Surgery within 2 months

结局指标

主要结局

Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score

时间窗: pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)

The primary objective was to assess whether the Age/Sex/Gene Expression Score (ASGES) altered clinicians' evaluations, defined by a change in patient management from preliminary to final decision. The change was prospectively defined as a downgrade or upgrade in intensity of the diagnostic plan based on the following hierarchical categories:(1) no further cardiac testing or treatment, (2) lifestyle changes or medical therapy, (3) stress testing (with or without imaging) or computed tomography/coronary angiography, or (4) invasive coronary angiography. The ASGES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. The changes in gene expression are quantified using an algorithm that generates a ASGES ranging from 1 to 40. A score \<=15 indicates a low risk of underlying obstructive coronary disease. The ASGES has a negative predictive value of 96% for ASGES \<=15 in a population referred to myocardial perfusion imaging.

次要结局

未报告次要终点

研究者

发起方
CardioDx
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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