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

Withdrawn

• Conditions: CAD; Coronary Heart Disease; Chest Pain; CVD; Coronary Artery Disease; Cardiovascular Diseases; CHD; Angina Pectoris
• Interventions: Diagnostic Test: Corus CAD (ASGES)

• Registration Number: NCT02158754
• Lead Sponsor: CardioDx

Brief Summary

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

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-09
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Corus CAD (ASGES)	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.

Primary Outcome Measures

Name	Time	Method
Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group.	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).

Secondary Outcome Measures

Name	Time	Method
Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects	120 days	Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects, allowing for physician-dependent rates.

Trial Locations

Locations (9)

Texas Familicare; 🇺🇸 Hurst, Texas, United States

Internet Medical Group; 🇺🇸 Rutherford, New Jersey, United States

Triangle Primary Care; 🇺🇸 Wake Forest, North Carolina, United States

J. Frank Martin, LLC; 🇺🇸 Columbia, South Carolina, United States

Comprehensive Physicians Associates, LLC; 🇺🇸 Youngstown, Ohio, United States

Northside Medical Center; 🇺🇸 Youngstown, Ohio, United States

Colonial Family Practice; 🇺🇸 Sumter, South Carolina, United States

Bells Medical Clinic; 🇺🇸 Bells, Texas, United States

South Carolina Internal Medicine Associates LLC; 🇺🇸 Irmo, South Carolina, United States