Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease (REGISTRY-I)

CardioDx

Status: Completed

Conditions: CVD; Coronary Artery Disease; CHD; CAD; Coronary Heart Disease; Chest Pain; Angina Pectoris; Cardiovascular Diseases

Treatments: Diagnostic Test: Corus CAD (ASGES)

Study type: Observational

Funder types: Industry

Identifiers

NCT01557855

CDX_000013

REGISTRY-I (Other Identifier)

Details and patient eligibility

About

The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.

Full description

This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.

Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:

1. No further cardiac testing or treatment
2. Medical therapy for angina or non-cardiac chest pain
3. Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.

Enrollment: 342 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion criteria

1. History of myocardial infarction

2. Current 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. Recipient of any organ transplant