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OpenTrials
Completed

NCT Number: NCT01557855

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Sun Family Medicine, Gilbert, Arizona, United States

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About this study

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:

  • No further cardiac testing or treatment
  • Medical therapy for angina or non-cardiac chest pain
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
  • The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion criteria

  • History of myocardial infarction
  • Current MI or acute coronary syndrome
  • Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
  • Any previous coronary Revascularization
  • Any individuals with:
  • Diabetes
  • Suspected unstable angina
  • Systemic infections
  • Systemic inflammatory conditions
  • Any individuals currently taking:
  • Steroids
  • Immunosuppressive agents
  • Chemotherapeutic agents
  • Recipient of any organ transplant

Treatment and study plan

Corus CAD (ASGES)

Diagnostic Test

Age/Sex/Gene Expression Score - ASGES

Primary outcomes

  1. Rate of referral vs. Corus CAD (ASGES) score as continuous variables

    Time frame: 30 Days

    Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days.

Secondary outcomes

  1. Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores.

    Time frame: 30 Day

    composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days.

Sponsors and collaborators

Lead sponsor

CardioDx

Industry

Registry information

Official study title

Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.

Acronym: REGISTRY-I

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2012
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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