Angina Pectoris, CAD, Cardiovascular Diseases, CHD, Chest Pain, Coronary Artery Disease, Coronary Heart Disease, CVD
Conditions
Keywords
Corus CAD, ASGES, Coronary Artery Disease, Gene Expression, Age/Sex/Gene Expression Score, GES, Angina Pectoris, Chest Pain, Cardiovascular Disease, CAD, CVD, CHD, Coronary Heart Disease, Precision Medicine, Clinical Utility
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.
Interventions
DIAGNOSTIC_TESTCorus CAD (ASGES)
Sponsors
CardioDx
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 2 years | Mace and procedure complications will be collected from Corus CAD (ASGES) draw/presentation through date of chart review. |
Countries
United States
Outcome results
None listed