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

Completed

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

• Registration Number: NCT01557855
• Lead Sponsor: CardioDx

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Study Start: 2012-04
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of referral vs. Corus CAD (ASGES) score as continuous variables	30 Days	Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days.

Secondary Outcome Measures

Name	Time	Method
Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores.	30 Day	composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days.

Trial Locations

Locations (7)

Triangle Primary Care; 🇺🇸 Wake Forest, North Carolina, United States

Arizona Sun Family Medicine; 🇺🇸 Gilbert, Arizona, United States

Town Lake Internal Medicine; 🇺🇸 Woodstock, Georgia, United States

Maringouin Medical Center; 🇺🇸 Maringouin, Louisiana, United States

The Bonin Clinic; 🇺🇸 Zachary, Louisiana, United States

Fiel Family Medicine; 🇺🇸 Tempe, Arizona, United States

Comprehensive Physicians Associates; 🇺🇸 Youngstown, Ohio, United States