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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02405754
Acronym
AACU
Enrollment
667
Registered
2015-04-01
Start date
2014-02-28
Completion date
2014-08-31
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Corus CAD, Personalized Medicine, CAD, ASGES, Age/Sex/Gene Expression Score, GES, CVD, CHD, Precision Medicine, Clinical Utility, Gene Expression, Coronary Heart Disease, Cardiovascular Disease, Chest Pain, Coronary Artery Disease, Angina Pectoris, exercise stress testing, CT angiography, invasive cardiac angiography, African-American patient, ICA, CTA

Brief 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.

Interventions

DIAGNOSTIC_TESTCorus CAD (ASGES)

Age/Sex/Gene Expression Score - ASGES

Sponsors

CardioDx
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CADExpected follow-up up to 1 year after receiving Corus CAD testingReferral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD , expected follow-up up to 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026