Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making

Study Overview
=================
Brief Summary
-----------------
This retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a Corus CAD (Age/Sex/Gene Expression score - ASGES) result compared to patients who did not have the test performed (matched control patients).

Detailed Description
-----------------
This retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a Corus CAD (Age/Sex/Gene Expression score - ASGES) result compared to patients who did not have the test performed (matched control patients). The data collected will be from primary care practices and will also assess one to two year health outcomes (MACE, procedure complications). Furthermore, in these real world practice settings, the study will investigate the economic impact of Corus CAD (ASGES) usage at each practice using practice specific data, when available.

Official Title
-----------------
Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Corus CAD (Age/Sex/Gene Expression score - ASGES) arm: Symptoms suggestive of obstructive CAD, according to the opinion of the site clinician Age >= 21 years Resulted Corus CAD (ASGES) test used during the evaluation and/or diagnosis of symptoms suggestive of obstructive coronary artery disease (CAD), preferably 1 year prior to data collection date. For Control arm: Symptoms suggestive of obstructive CAD, according to the opinion of the site clinician Eligible for Corus CAD (ASGES) (see exclusion criteria) Matched to Corus CAD (ASGES) patients by sex, age +/-2.5 years, and presenting symptoms Exclusion Criteria: History of myocardial infarction (MI) or CAD prior to the index evaluation Presentation of high risk unstable angina for the index evaluation Concurrent systemic infection or inflammatory process Concurrent MI or acute coronary syndrome Known diabetes mellitus diagnosis or laboratory test results suggestive of a diagnosis of diabetes mellitus (e.g., HbA1C >=6.5) Use of steroids, immunosuppressive agents, or chemotherapeutic agents, at time of chest pain presentation

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Corus CAD (ASGES)<br>Subjects receiving CorusCAD (ASGES) gene expression test as part of their diagnostic workup for typical and/or atypical symptoms of obstructive coronary artery disease. | Diagnostic Test: Corus CAD (ASGES)<br> <br> |
| Control<br>Matched subjects in the same practice that did NOT receive Corus CAD (ASGES) as part of their diagnostic workup. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group. | The primary endpoint of the study is the change in number of advanced cardiac diagnostic tests (exercise ECG, stress myocardial perfusion imaging (MPI), cardiac computed tomography angiography (CCTA) or invasive coronary angiography (ICA)) ordered and number of subject referrals to specialty care by the primary clinician, comparing low score Corus CAD (<=15) patients (Corus CAD arm) and matched control patients who did not receive Corus CAD testing (control arm). | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects | Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects, allowing for physician-dependent rates. | 120 days | 

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