Trials / Completed
CompletedNCT02405754
Clinical Utility of an Age, Sex, and Gene Expression Score (ASGES or Corus CAD) in African American Patients.
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 667 (actual)
- Sponsor
- CardioDx · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Coronary Artery Disease
- Angina Pectoris
- Chest Pain
- Cardiovascular Diseases
- Coronary Heart Disease
- CHD
- CVD
- CAD
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Corus CAD (ASGES) | Age/Sex/Gene Expression Score - ASGES |
Timeline
- Start date
- 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 across 1 country: United States
Source: ClinicalTrials.gov record NCT02405754. Inclusion in this directory is not an endorsement.