Angina Pectoris, CAD, Cardiovascular Diseases, CHD, Chest Pain, Coronary Artery Disease, Coronary Heart Disease, CVD
Conditions
Keywords
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
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.
Interventions
DIAGNOSTIC_TESTCorus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES
Sponsors
CardioDx
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision | Up to 7 days | 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 |
| Change in management practice pattern between after Corus CAD decision and historical cohort. | up to 195 days | 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 |
Countries
United States
Outcome results
None listed