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

January 29, 2019 updated by: CardioDx

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

342

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85296
        • Arizona Sun Family Medicine
      • Tempe, Arizona, United States, 85283
        • Fiel Family Medicine
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • Town Lake Internal Medicine
    • Louisiana
      • Maringouin, Louisiana, United States, 70757
        • Maringouin Medical Center
      • Zachary, Louisiana, United States, 70791
        • The Bonin Clinic
    • North Carolina
      • Wake Forest, North Carolina, United States, 27587
        • Triangle Primary Care
    • Ohio
      • Youngstown, Ohio, United States, 44505
        • Comprehensive Physicians Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects will be enrolled at multiple qualified participating study centers that have incorporated Corus CAD (ASGES) for the diagnosis of obstructive CAD into their routine practice.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of myocardial infarction
  2. Current MI or acute coronary syndrome
  3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
  4. Any previous coronary Revascularization

  5. Any individuals with:

    • Diabetes
    • Suspected unstable angina
    • Systemic infections
    • Systemic inflammatory conditions

  6. Any individuals currently taking:

    • Steroids
    • Immunosuppressive agents
    • Chemotherapeutic agents
  7. Recipient of any organ transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioDx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 20, 2012

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX_000013
  • REGISTRY-I (OTHER: CardioDx)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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