Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making (UCU-CARD)

February 21, 2018 updated by: CardioDx
The purpose of this study is to understand the use of Corus CAD also known as Age/Sex/Gene Expression score (ASGES) in the clinical decision making process of patients who underwent the evaluation of chest pain or anginal equivalent symptoms. Specifically, to better understand whether the use of the assay in clinical decision making resulted in changes in noninvasive diagnostic test ordering or diagnostic yield of additional tests ordered and/or invasive angiography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The UCU-CARD (Understanding Clinician Utility-Cardiology) study is a retrospective, matched-cohort evaluation of diagnostic testing in a community-based cardiology practice setting that used a personalized age, sex, and gene expression test during early work-up of patients with symptoms suggestive of obstructive CAD (http://www.clinicaltrials.gov, NCT02223286). The study measured the rates of advanced cardiac diagnostic testing after initial work-up, including stress testing with imaging, CTA, or ICA. Rates of advanced diagnostic testing for patients who received the age, sex, and gene expression test (ASGES) were compared with testing rates for matched historical controls (usual care). The study hypothesis was that incorporating the age, sex, and gene expression testing early in the diagnostic work-up pathway would permit the identification of patients for whom advanced diagnostic testing was not required, thereby avoiding unnecessary testing and enabling cardiologists to focus their diagnostic resources more efficiently.

This single-center study was conducted at the North Phoenix Heart Center (Phoenix, AZ), a community-based group cardiology practice that receives patients on referral from primary care physicians and other specialists in the surrounding area. The practice incorporated age, sex, and gene expression testing into its diagnostic protocol beginning in June 2011. Data collection was completed in December 2013. Institutional Review Board (IRB) approval of the study protocol was granted by Quorum Review. Informed consent waivers were granted as data collection was retrospective and all data were de-identified.

Study Type

Observational

Enrollment (Actual)

552

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
      • Phoenix, Arizona, United States, 85037
        • John C. Lincoln Heart Institute
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • Piedmont Heart Institute
    • Ohio
      • Youngstown, Ohio, United States, 44504
        • Heart 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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patient population of interest and the main inclusion criterion for inclusion is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction, and the utilization of Corus CAD (Age/Sex/Gene Expression score - ASGES).

Additionally, subjects with similar chest pain (or angina equivalent) whom did not undergo Corus CAD (ASGES) will be included as a control group, to understand the diagnostic evaluation and management of patients prior to Corus CAD (ASGES) use.

Description

Inclusion Criteria:

  1. Symptoms suggestive of CAD, according to the opinion of the site clinician
  2. Age >= 21 years

Exclusion Criteria:

  1. History of myocardial infarction (MI)
  2. History of high risk unstable angina, systemic infections or systemic inflammatory conditions
  3. Current MI or acute coronary syndrome
  4. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
  5. Known/documented CAD
  6. History/current Diabetes Mellitus
  7. Taking steroids, immunosuppressive agents, or chemotherapeutic agents, at time of chest pain presentation

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
ASGES (Treatment Group)
Patients who received a Corus CAD or Age/Sex/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD
Diagnostic test: Corus CAD
Age/Sex/Gene Expression Score
Non-ASGES (Control Group)
Patients who underwent usual care testing and did not receive a Corus CAD or Age/SEX/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary measure of this study is the number of advanced diagnostic tests in ASGES (treatment group) patients compared to the number of advanced diagnostic tests in non-ASGES (control group) patients.
Time Frame: up to 24 months
The primary study endpoint was the percentage of patients for whom advanced diagnostic testing was ordered-stress testing with imaging, computed tomography angiography, or invasive coronary angiography.
up to 24 months

Collaborators and Investigators

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

Sponsor

CardioDx

Investigators

  • Principal Investigator: David Hoffman, DO, Northeast Ohio Medical University
  • Principal Investigator: Lawrence Kline, DP, John C. Lincoln Heart Institute
  • Principal Investigator: Jaime Burkle, MD, Piedmont Heart Institute

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

March 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX_000016
  • UCU-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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