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

Coronary Artery Disease Clinical Trial

— CU-PCP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02158754
• Other study ID #: CDX_000021
• Secondary ID: CU-PCP
• Status: Withdrawn
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2019
• Source: CardioDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Corus CAD (ASGES)

Locations

Country	Name	City	State
United States	Bells Medical Clinic	Bells	Texas
United States	J. Frank Martin, LLC	Columbia	South Carolina
United States	Texas Familicare	Hurst	Texas
United States	South Carolina Internal Medicine Associates LLC	Irmo	South Carolina
United States	Internet Medical Group	Rutherford	New Jersey
United States	Colonial Family Practice	Sumter	South Carolina
United States	Triangle Primary Care	Wake Forest	North Carolina
United States	Comprehensive Physicians Associates, LLC	Youngstown	Ohio
United States	Northside Medical Center	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
CardioDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Mace and procedure complications will be collected from Corus CAD (ASGES) draw/presentation through date of chart review.	up to 2 years
Primary	Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group.	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	Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects	Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects, allowing for physician-dependent rates.	120 days