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

Completed

• Conditions: CVD; Angina Pectoris; CHD; Chest Pain; Coronary Heart Disease; Coronary Artery Disease; Cardiovascular Diseases; CAD
• Interventions: Diagnostic Test: Corus CAD (ASGES)

• Registration Number: NCT02405754
• Lead Sponsor: CardioDx

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-31
• Study First Posted: 2015-04-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Group	Corus CAD (ASGES)	Patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD test

Primary Outcome Measures

Name	Time	Method
Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD	Expected follow-up up to 1 year after receiving Corus CAD testing	Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD , expected follow-up up to 1 year

Trial Locations

Locations (1)

Providence Medical Group - Dayton Primary; 🇺🇸 Dayton, Ohio, United States