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| ID | Type | Description | Link |
|---|---|---|---|
| IMPACT-CARD | Other Identifier | CardioDx |
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To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.
A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Cohort | Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis. |
| |
| Retrospective Cohort | Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) to assist in diagnosis. Note: this cohort was historical. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corus CAD (ASGES) | Diagnostic Test | Age/Sex/Gene Expression Score - ASGES |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision | Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:
| Up to 7 days |
| Change in management practice pattern between after Corus CAD decision and historical cohort. | Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:
| up to 195 days |
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Inclusion Criteria:
Exclusion Criteria:
History of myocardial infarction
Current myocardial infarct (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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The study will enroll a patient population that present with chest pain or anginal equivalent symptoms who are referred to a cardiologist for evaluation.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Zapien, MS | CardioDx, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23680805 | Result | McPherson JA, Davis K, Yau M, Beineke P, Rosenberg S, Monane M, Fredi JL. The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery disease: results from the IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial. Crit Pathw Cardiol. 2013 Jun;12(2):37-42. doi: 10.1097/HPC.0b013e3182822bd0. |
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PaxGene tube for RNA collected
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D003324 | Coronary Artery Disease |
| D002637 | Chest Pain |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D050197 | Atherosclerosis |
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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