Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern (IMPACT-CARD)

January 29, 2019 updated by: CardioDx

Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern

To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.

Study Type

Observational

Enrollment (Actual)

171

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
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will enroll a patient population that present with chest pain or anginal equivalent symptoms who are referred to a cardiologist for evaluation.

Description

Inclusion Criteria:

  1. Stable chest pain, typical or atypical angina or anginal equivalent
  2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.

Exclusion Criteria:

  1. History of myocardial infarction
  2. Current myocardial infarct (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:

    1. Diabetes
    2. Suspected unstable angina
    3. Systemic infections
    4. Systemic inflammatory conditions

  6. Any individuals currently taking:

    1. Steroids
    2. Immunosuppressive agents
    3. 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective Cohort
Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis.
Diagnostic test: Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES
Retrospective Cohort
Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) to assist in diagnosis. Note: this cohort was historical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision
Time Frame: Up to 7 days

Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:

  1. No further cardiac testing or treatment
  2. Medical therapy for angina or non-cardiac chest pain
  3. Stress testing with or without imaging
  4. CT angiography
  5. Invasive cardiac catheterization
Up to 7 days
Change in management practice pattern between after Corus CAD decision and historical cohort.
Time Frame: up to 195 days

Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:

  1. No further cardiac testing or treatment
  2. Medical therapy for angina or non-cardiac chest pain
  3. Stress testing with or without imaging
  4. CT angiography
  5. Invasive cardiac catheterization
up to 195 days

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

November 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

November 30, 2010

First Posted (Estimate)

December 1, 2010

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_000011
  • IMPACT-CARD (Other Identifier: 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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