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

Study Overview
=================
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: No further cardiac testing or treatment Medical therapy for angina or non-cardiac chest pain 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.

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.

Conditions
-----------------
CAD, Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CVD, CHD

Intervention / Treatment
-----------------
* Diagnostic Test: Corus CAD (ASGES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent The patient has signed the appropriate Institutional Review Board approved Informed Consent Form Exclusion Criteria: History of myocardial infarction Current MI or acute coronary syndrome Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms Any previous coronary Revascularization Any individuals with: Diabetes Suspected unstable angina Systemic infections Systemic inflammatory conditions Any individuals currently taking: Steroids Immunosuppressive agents Chemotherapeutic agents Recipient of any organ transplant

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Corus CAD (ASGES)|Age/Sex/Gene Expression Score - ASGES|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Utility, Registry, Coronary Artery Disease, Coronary Heart Disease, Cardiovascular Disease, Angina Pectoris, Chest Pain, Registry I, Registry-I, Corus CAD, ASGES, Age/Sex/Gene Expression Score, Gene Expression, GES, CAD, CVD, CHD, Precision Medicine