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| ID | Type | Description | Link |
|---|---|---|---|
| REGISTRY-I | Other Identifier | CardioDx |
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The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.
This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.
Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:
Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corus CAD (ASGES) | Diagnostic Test | Age/Sex/Gene Expression Score - ASGES |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of referral vs. Corus CAD (ASGES) score as continuous variables | Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores. | composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days. | 30 Day |
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Inclusion Criteria:
Exclusion Criteria:
History of myocardial infarction
Current MI or acute coronary syndrome
Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
Any previous coronary Revascularization
Any individuals with:
Any individuals currently taking:
Recipient of any organ transplant
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Subjects will be enrolled at multiple qualified participating study centers that have incorporated Corus CAD (ASGES) for the diagnosis of obstructive CAD into their routine practice.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Zapien, MS | CardioDx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Sun Family Medicine | Gilbert | Arizona | 85296 | United States | ||
| Fiel Family Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24798176 | Result | Ladapo JA, Lyons H, Yau M, Rich P, Newton D, Bruce-Mensah K, Johnson A, Zhou Y, Stemkowski S, Monane M. Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test: results from a prospective registry study. Am J Med Qual. 2015 Jul-Aug;30(4):345-52. doi: 10.1177/1062860614532517. Epub 2014 May 5. | |
| 25828395 |
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| Tempe |
| Arizona |
| 85283 |
| United States |
| Town Lake Internal Medicine | Woodstock | Georgia | 30189 | United States |
| Maringouin Medical Center | Maringouin | Louisiana | 70757 | United States |
| The Bonin Clinic | Zachary | Louisiana | 70791 | United States |
| Triangle Primary Care | Wake Forest | North Carolina | 27587 | United States |
| Comprehensive Physicians Associates | Youngstown | Ohio | 44505 | United States |
| Derived |
| Ladapo JA, Herman L, Weiner BH, Rhees B, Castle L, Monane M, McPherson JA. Use of a blood test incorporating age, sex, and gene expression influences medical decision-making in the evaluation of women presenting with symptoms suggestive of obstructive coronary artery disease: summary results from two ambulatory care studies in primary care. Menopause. 2015 Nov;22(11):1224-30. doi: 10.1097/GME.0000000000000443. |
| 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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