Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern

Study Overview
=================
Brief Summary
-----------------
To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.

Detailed Description
-----------------
A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.

Official Title
-----------------
Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable chest pain, typical or atypical angina or anginal equivalent The patient has signed the appropriate Institutional Review Board approved Informed Consent Form. Exclusion Criteria: History of myocardial infarction Current myocardial infarct (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
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Cohort<br>Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis. | Diagnostic Test: Corus CAD (ASGES)<br>* Age/Sex/Gene Expression Score - ASGES<br>|
| Retrospective Cohort<br>Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) to assist in diagnosis. Note: this cohort was historical. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision | Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: No further cardiac testing or treatment Medical therapy for angina or non-cardiac chest pain Stress testing with or without imaging CT angiography Invasive cardiac catheterization | Up to 7 days | 
| Change in management practice pattern between after Corus CAD decision and historical cohort. | Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: No further cardiac testing or treatment Medical therapy for angina or non-cardiac chest pain Stress testing with or without imaging CT angiography Invasive cardiac catheterization | up to 195 days | 

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