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| ID | Type | Description | Link |
|---|---|---|---|
| CU-PCP | Other Identifier | CardioDx |
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Study halted due to low investigator involvement; no patients enrolled in study.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Control | Matched subjects in the same practice that did NOT receive Corus CAD (ASGES) as part of their diagnostic workup. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corus CAD (ASGES) | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
For Corus CAD (Age/Sex/Gene Expression score - ASGES) arm:
For Control arm:
Exclusion Criteria:
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This study is a retrospective chart review, in which only de-identified clinical data will be collected and analyzed. The main criterion for inclusion is the occurrence of chest pain (or anginal equivalent) in a subject without known significant CAD or a history of prior myocardial infarction, and the utilization of Corus CAD (Age/Sex/Gene Expression score - ASGES) for the Corus CAD Arm. Additionally, Corus CAD (ASGES) eligible subjects with similar chest pain (or angina equivalent) who did not undergo Corus CAD (ASGES) testing will be included as a control group.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Monane, MD, FACP | CardioDx | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internet Medical Group | Rutherford | New Jersey | 07070 | United States | ||
| Triangle Primary Care |
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| Wake Forest |
| North Carolina |
| 27587 |
| United States |
| Comprehensive Physicians Associates, LLC | Youngstown | Ohio | 44505 | United States |
| Northside Medical Center | Youngstown | Ohio | 44505 | United States |
| J. Frank Martin, LLC | Columbia | South Carolina | 29229 | United States |
| South Carolina Internal Medicine Associates LLC | Irmo | South Carolina | 29063 | United States |
| Colonial Family Practice | Sumter | South Carolina | 29150 | United States |
| Bells Medical Clinic | Bells | Texas | 75414 | United States |
| Texas Familicare | Hurst | Texas | 76054 | United States |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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