NCT01594411

PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 251 (actual)
• Sponsor: CardioDx · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chest Pain
• Cardiovascular Diseases
• Angina Pectoris
• Coronary Artery Disease
• CAD
• CVD
• CHD
• Coronary Heart Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Corus CAD	Age/Sex/Gene Expression Score (ASGES)

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2012-05-09
• Last updated: 2019-01-31
• Results posted: 2014-04-23

Locations

4 sites across 1 country: United States