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

Coronary Artery Disease Clinical Trial

— REGISTRY-I  

Official title:

Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557855
• Other study ID #: CDX_000013
• Secondary ID: REGISTRY-I
• Status: Completed
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2019
• Source: CardioDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES

Locations

Country	Name	City	State
United States	Arizona Sun Family Medicine	Gilbert	Arizona
United States	Maringouin Medical Center	Maringouin	Louisiana
United States	Fiel Family Medicine	Tempe	Arizona
United States	Triangle Primary Care	Wake Forest	North Carolina
United States	Town Lake Internal Medicine	Woodstock	Georgia
United States	Comprehensive Physicians Associates	Youngstown	Ohio
United States	The Bonin Clinic	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
CardioDx

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ladapo JA, Lyons H, Yau M, Rich P, Newton D, Bruce-Mensah K, Johnson A, Zhou Y, Stemkowski S, Monane M. Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test: resul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of referral vs. Corus CAD (ASGES) score as continuous variables	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.	30 Days
Secondary	Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores.	composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days.	30 Day