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| ID | Type | Description | Link |
|---|---|---|---|
| EXERCISE | Other Identifier | CardioDx |
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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This is a prospective, single-center study that aims to evaluate the acute and delayed effect of exercise stress testing on the peripheral gene expression (PGE) levels using a predefined gene set established in the Corus CAD (Age/Sex/Gene Expression score - ASGES) test in subject with known obstructive coronary artery disease (CAD) and in control subjects (without known CAD).
This is a prospective, single-center study. This protocol is a pilot study to investigate the effects of "acute" exercise (by exercise stress testing; modified Bruce protocol) on peripheral gene expression (PGE) levels as measured by Corus CAD score (Age/Sex/Gene Expression score - ASGES). Subjects will have blood sampling at baseline, at peak exercise, within 30 to 60 minutes post-exercise, at 24-36 hours post-exercise. The study will be stratified by presence of CAD and gender. An equal number of subjects with known CAD and normal controls will be enrolled. Equally, an equal number of men and women will be included. A screening CBC and HgbA1c will be performed to ensure the subject meets the intended use instruction for Corus CAD (ASGES). Data collection will include presence or absence of ECG ischemia with testing, as well as heart rate and blood pressure response to exercise with other ECG and dynamic variables. There will be four blood samples taken per subject as shown in the figure below.
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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 |
|---|---|---|
| Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline | up to 1 months |
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Inclusion Criteria:
Exclusion Criteria:
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Non-diabetic subjects will be enrolled at the Department of Cardiology, Mayo Clinic, Florida. Enrollment will not be randomized. Subjects will be enrolled based on achieving an equal number of men and women, and known Coronary Artery Disease or CAD (prior history of ischemia by stress test or a coronary catheterization documenting greater than or equal to 50% stenosis in any vessels within 12 months prior to enrollment) and no known CAD (controls - prior of history of coronary catheterization documenting less than or equal to 15% stenosis in any vessels within 12 months prior to enrollment). Enrollment will be stratified as shown below:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Zapien, MS | CardioDx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Research Unit | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Publication: Impact of Exercise Stress Testing on Diagnostic Gene Expression in Patients With Obstructive and Nonobstructive Coronary Artery Disease | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D050197 | Atherosclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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RNA PAXgene
| D014652 |
| Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |