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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02158754
Other study ID # CDX_000021
Secondary ID CU-PCP
Status Withdrawn
Phase
First received
Last updated
Start date May 2014
Est. completion date June 2015

Study information

Verified date January 2019
Source CardioDx
Contact n/a
Is FDA regulated No
Health authority
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Status Withdrawn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

Study Design


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
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