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

NCT02405754 | Completed

• 2 other identifiers: CDX_000024AACU
• Study Type: observational
• Target: 667
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment Group

Patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD test

Diagnostic Test: Corus CAD (ASGES)

Interventions

Corus CAD (ASGES) DIAGNOSTIC_TEST

Age/Sex/Gene Expression Score - ASGES

Treatment Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients receiving Corus CAD (ASGES) from 2008-2012.

You may not qualify if:

• 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:
• History of diabetes;
• Revascularization or myocardial infarction;
• Systemic infection or inflammatory condition; or
• Use of steroids, immunosuppressive agents, or chemotherapeutic agents.

Sponsors & Collaborators

• CardioDx: lead

Study Sites (1)

Providence Medical Group - Dayton Primary

Dayton, Ohio, 45402, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Diseases; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda Ross, MPH

  CardioDx, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 1, 2015
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

US (1)