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

CardioDx171 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

171

Conditions

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Stable chest pain, typical or atypical angina or anginal equivalent 2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form. Exclusion Criteria: 1. History of myocardial infarction 2. Current myocardial infarct (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: 1. Diabetes 2. Suspected unstable angina 3. Systemic infections 4. Systemic inflammatory conditions 6. Any individuals currently taking: 1. Steroids 2. Immunosuppressive agents 3. Chemotherapeutic agents 7. Recipient of any organ transplant

Outcomes

Primary Outcomes

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: 1. No further cardiac testing or treatment 2. Medical therapy for angina or non-cardiac chest pain 3. Stress testing with or without imaging 4. CT angiography 5. Invasive cardiac catheterization

Time frame: 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: 1. No further cardiac testing or treatment 2. Medical therapy for angina or non-cardiac chest pain 3. Stress testing with or without imaging 4. CT angiography 5. Invasive cardiac catheterization

Time frame: up to 195 days