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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Chest Pain; Angina Pectoris; Coronary Heart Disease; CAD; CHD; CVD
• Intervention / Treatment: Diagnostic test: Corus CAD (ASGES)

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 Type: Observational
• Enrollment (Actual): 667

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45402
      • Providence Medical Group - Dayton Primary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects, who received Age/Sex/Gene Expression Score (ASGES) or Corus CAD testing, will be considered for enrollment by conducting a retrospective review of medical charts. Subjects who satisfy the following inclusion and exclusion criteria will be included for data abstraction.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; Patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD test	Diagnostic test: Corus CAD (ASGES); Age/Sex/Gene Expression Score - ASGES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CardioDx
• Investigators: Study Director: Linda Ross, MPH, CardioDx, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimate): April 1, 2015

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Cardiovascular Disease; Personalized Medicine; Gene Expression; CHD; Precision Medicine; CTA; CT angiography; CAD; Coronary Heart Disease; Chest Pain; exercise stress testing; GES; CVD; Angina Pectoris; Corus CAD; ASGES; Age/Sex/Gene Expression Score; Clinical Utility; ICA; invasive cardiac angiography; African-American patient
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Chest Pain; Angina Pectoris
• Other Study ID Numbers: CDX_000024; AACU (Other Identifier: CardioDx)