Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making (CU-PCP)

January 29, 2019 updated by: CardioDx
This retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a Corus CAD (Age/Sex/Gene Expression score - ASGES) result compared to patients who did not have the test performed (matched control patients).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a Corus CAD (Age/Sex/Gene Expression score - ASGES) result compared to patients who did not have the test performed (matched control patients). The data collected will be from primary care practices and will also assess one to two year health outcomes (MACE, procedure complications). Furthermore, in these real world practice settings, the study will investigate the economic impact of Corus CAD (ASGES) usage at each practice using practice specific data, when available.

Study Type

Observational

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
    • New Jersey
      • Rutherford, New Jersey, United States, 07070
        • Internet Medical Group
    • North Carolina
      • Wake Forest, North Carolina, United States, 27587
        • Triangle Primary Care
    • Ohio
      • Youngstown, Ohio, United States, 44505
        • Northside Medical Center
      • Youngstown, Ohio, United States, 44505
        • Comprehensive Physicians Associates, LLC
    • South Carolina
      • Columbia, South Carolina, United States, 29229
        • J. Frank Martin, LLC
      • Irmo, South Carolina, United States, 29063
        • South Carolina Internal Medicine Associates LLC
      • Sumter, South Carolina, United States, 29150
        • Colonial Family Practice
    • Texas
      • Bells, Texas, United States, 75414
        • Bells Medical Clinic
      • Hurst, Texas, United States, 76054
        • Texas Familicare

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

Non-Probability Sample

Study Population

This study is a retrospective chart review, in which only de-identified clinical data will be collected and analyzed. The main criterion for inclusion is the occurrence of chest pain (or anginal equivalent) in a subject without known significant CAD or a history of prior myocardial infarction, and the utilization of Corus CAD (Age/Sex/Gene Expression score - ASGES) for the Corus CAD Arm. Additionally, Corus CAD (ASGES) eligible subjects with similar chest pain (or angina equivalent) who did not undergo Corus CAD (ASGES) testing will be included as a control group.

Description

Inclusion Criteria:

For Corus CAD (Age/Sex/Gene Expression score - ASGES) arm:

  • Symptoms suggestive of obstructive CAD, according to the opinion of the site clinician
  • Age >= 21 years
  • Resulted Corus CAD (ASGES) test used during the evaluation and/or diagnosis of symptoms suggestive of obstructive coronary artery disease (CAD), preferably 1 year prior to data collection date.

For Control arm:

  • Symptoms suggestive of obstructive CAD, according to the opinion of the site clinician
  • Eligible for Corus CAD (ASGES) (see exclusion criteria)
  • Matched to Corus CAD (ASGES) patients by sex, age +/-2.5 years, and presenting symptoms

Exclusion Criteria:

  • History of myocardial infarction (MI) or CAD prior to the index evaluation
  • Presentation of high risk unstable angina for the index evaluation
  • Concurrent systemic infection or inflammatory process
  • Concurrent MI or acute coronary syndrome
  • Known diabetes mellitus diagnosis or laboratory test results suggestive of a diagnosis of diabetes mellitus (e.g., HbA1C >=6.5)
  • Use of 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
Corus CAD (ASGES)
Subjects receiving CorusCAD (ASGES) gene expression test as part of their diagnostic workup for typical and/or atypical symptoms of obstructive coronary artery disease.
Diagnostic test: Corus CAD (ASGES)
Control
Matched subjects in the same practice that did NOT receive Corus CAD (ASGES) as part of their diagnostic workup.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group.
Time Frame: 120 days
The primary endpoint of the study is the change in number of advanced cardiac diagnostic tests (exercise ECG, stress myocardial perfusion imaging (MPI), cardiac computed tomography angiography (CCTA) or invasive coronary angiography (ICA)) ordered and number of subject referrals to specialty care by the primary clinician, comparing low score Corus CAD (<=15) patients (Corus CAD arm) and matched control patients who did not receive Corus CAD testing (control arm).
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects
Time Frame: 120 days
Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects, allowing for physician-dependent rates.
120 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health outcomes ( MACE, procedure complications) between Corus CAD (ASGES) subjects and control subjects, between low score Corus CAD subjects and matched control subjects, and between low score Corus CAD subjects and non-low score Corus CAD subjects
Time Frame: up to 2 years
Mace and procedure complications will be collected from Corus CAD (ASGES) draw/presentation through date of chart review.
up to 2 years

Collaborators and Investigators

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

Sponsor

CardioDx

Investigators

  • Study Chair: Mark Monane, MD, FACP, CardioDx

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

May 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 9, 2014

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_000021
  • CU-PCP (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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