Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for

Status Completed

Clinical Trial Summary

The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.

Clinical Trial Description

This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.

Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:

1. No further cardiac testing or treatment

2. Medical therapy for angina or non-cardiac chest pain

3. Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01557855
Study type	Observational
Source	CardioDx
Contact
Status	Completed
Phase
Start date	April 2012
Completion date	May 2013

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Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease — REGISTRY-I

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms