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

Completed

• Conditions: Angina Pectoris; CVD; Coronary Heart Disease; CAD; CHD; Cardiovascular Diseases; Coronary Artery Disease; Chest Pain
• Interventions: Diagnostic Test: Corus CAD

• Registration Number: NCT01594411
• Lead Sponsor: CardioDx

Brief 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Results First Submitted: 2013-09-03
• Results First Submitted QC: 2014-04-15
• Results First Posted: 2014-04-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

1. Stable chest pain, typical or atypical angina or anginal equivalent
2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.

Exclusion Criteria

1. History of myocardial infarction

2. Current Myocardial infarction (MI) or acute coronary syndrome.

3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms.

4. Any previous coronary revascularization.

5. Any individuals with :

   • Diabetes
   • Suspected unstable angina
   • Systemic infections
   • Systemic inflammatory conditions

6. Any individuals currently taking:

   • Steroids
   • Immunosuppressive agents
   • Chemotherapeutic agents

7. Any Major Surgery within 2 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects	Corus CAD	Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant coronary artery disease (CAD) or a history of prior myocardial infarction.

Primary Outcome Measures

Name	Time	Method
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score	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.

Trial Locations

Locations (4)

John's Creek Primary Care; 🇺🇸 Suwanee, Georgia, United States

Carolina Family Healthcare; 🇺🇸 Charlotte, North Carolina, United States

The Lipid Center; 🇺🇸 Baton Rouge, Louisiana, United States

Family Care Clinic; 🇺🇸 Bonham, Texas, United States