Coronary Artery Disease Clinical Trial
— CU-PCPOfficial title:
Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making
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Status | Withdrawn |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 |
Verified date | January 2019 |
Source | CardioDx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Withdrawn |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 |
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 |
Lead Sponsor | Collaborator |
---|---|
CardioDx |
United States,
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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