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

NCT ID: NCT02158754

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Coronary Artery Disease Angina Pectoris Chest Pain Cardiovascular Diseases CAD CVD Coronary Heart Disease CHD

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Corus CAD (ASGES)

Intervention Type DIAGNOSTIC_TEST

Control

Matched subjects in the same practice that did NOT receive Corus CAD (ASGES) as part of their diagnostic workup.

No interventions assigned to this group

Interventions

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Corus CAD (ASGES)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Exclusion Criteria

* Matched to Corus CAD (ASGES) patients by sex, age +/-2.5 years, and presenting symptoms


* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioDx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Monane, MD, FACP

Role: STUDY_CHAIR

CardioDx

Locations

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Internet Medical Group

Rutherford, New Jersey, United States

Site Status

Triangle Primary Care

Wake Forest, North Carolina, United States

Site Status

Comprehensive Physicians Associates, LLC

Youngstown, Ohio, United States

Site Status

Northside Medical Center

Youngstown, Ohio, United States

Site Status

J. Frank Martin, LLC

Columbia, South Carolina, United States

Site Status

South Carolina Internal Medicine Associates LLC

Irmo, South Carolina, United States

Site Status

Colonial Family Practice

Sumter, South Carolina, United States

Site Status

Bells Medical Clinic

Bells, Texas, United States

Site Status

Texas Familicare

Hurst, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CU-PCP

Identifier Type: OTHER

Identifier Source: secondary_id

CDX_000021

Identifier Type: -

Identifier Source: org_study_id

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