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

CardioDx

Status: Withdrawn

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

Treatments: Diagnostic Test: Corus CAD (ASGES)

Study type: Observational

Funder types: Industry

Identifiers

NCT02158754

CU-PCP (Other Identifier)

CDX_000021

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Corus CAD (ASGES)

Description:

Subjects receiving CorusCAD (ASGES) gene expression test as part of their diagnostic workup for typical and/or atypical symptoms of obstructive coronary artery disease.

Treatment:

Diagnostic Test: Corus CAD (ASGES)

Control

Description:

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