Clinical Utility of an Age, Sex, and Gene Expression Score (ASGES or Corus CAD) in African American Patients.

Coronary Artery Disease Clinical Trial

— AACU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405754
• Other study ID #: CDX_000024
• Secondary ID: AACU
• Status: Completed
• Start date: February 2014
• Est. completion date: August 2014

Study information

• Verified date: January 2019
• Source: CardioDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES

Locations

Country	Name	City	State
United States	Providence Medical Group - Dayton Primary	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
CardioDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD	Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD , expected follow-up up to 1 year	Expected follow-up up to 1 year after receiving Corus CAD testing