Clinical Utility of an Age, Sex and Gene Expression Score (ASGES or Corus CAD) in the Diagnostic Management of Obstructive Coronary Artery Disease in African American Patients in a Primary Care Setting
| Registry | NCT02405754, acronym AACU |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 667 (Actual) |
| Sponsor | CardioDx (Industry) |
| Conditions | Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CHD, CVD, CAD |
| Interventions | Corus CAD (ASGES) (Diagnostic test) |
| Dates | start 2014-02-01, primary completion 2014-04-01, completion 2014-08-01, first posted 2015-04-01, last updated 2019-01-31 |
| Locations | 1 site in United States |
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This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Age/Sex/Gene Expression score (ASGES) also knows as Corus CAD testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously.
Though the diagnostic properties of Age/Sex/Gene Expression Score (ASGES) or Corus CAD have been evaluated in previous observational studies, there are limited data regarding how primary care clinicians are using the results of the test in the care and management of patients with symptoms suggestive of angina in the African-America patient population. This retrospective study is designed to examine the relationship between the Corus CAD (ASGES) score and patterns of care regarding cardiology referral or further cardiac diagnostic testing in an African-American patient population single-center site.
This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Corus CAD (ASGES) testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously. IRB approval will be requested with a waiver of informed consent, as no identifying information will be collected.
This retrospective study is designed to understand the patterns of care, including referrals for cardiac care and testing (including referrals to a cardiologist, exercise stress testing, cardiac computerized tomography angiography (CCTA), invasive cardiac angiography (ICA)) within an African-American patient population.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Treatment Group | Diagnostic Test: Corus CAD (ASGES) | Patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD test |
Sex: All, ages: 21 Years to any
Inclusion Criteria: * All patients receiving Corus CAD (ASGES) from 2008-2012. Exclusion Criteria: * If any of the following co-moribidities, medical conditions, or current medical statuses are noted in the patient medical chart, s/he will be excluded from the analysis dataset: 1. History of diabetes; 2. Revascularization or myocardial infarction; 3. Systemic infection or inflammatory condition; or 4. Use of steroids, immunosuppressive agents, or chemotherapeutic agents.
| Facility | City | Country | Status |
|---|---|---|---|
| Providence Medical Group - Dayton Primary | Dayton, Ohio | United States |