Coronary Artery Disease Clinical Trial
— EXERCISEOfficial title:
Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD Diagnostic Test (Age, Sex, Gene Expression Score ASGES).
Verified date | January 2019 |
Source | CardioDx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Ages 45-75 years old 2. Able to perform an adequate exercise stress test 3. Subjects with no known CAD and subjects with known CAD subjects Exclusion Criteria: 1. Known severe CAD that will be unsafe to exercise stress patient 2. Current MI or high-risk acute coronary syndrome (including high-risk unstable angina 3. NYHA class III or IV congestive heart failure 4. Severe regurgitant or stenotic cardiac valvular lesion 5. Severe left ventricular systolic dysfunction 6. Active systemic infection in the preceding 2 months or chronic infection (e.g. HIV, Hepatitis B or C, Tuberculosis)**. 7. Protocol-specified rheumatologic, autoimmune or hematologic conditions 8. Known or suspected diabetes mellitus or documented Hemoglobin A1C (A test for people with diabetes that monitors their average blood sugar levels over a period of two to three months) percent within last 6 months; presume normal HgbA1c (used as a standard tool to determine blood sugar control for patients with diabetes.) if none documented. 9. Total WBC 11,000/ul from a CBC drawn within 7 days of enrollment 10. Inadequate exercise stress test. 11. Recipient of any organ transplant 12. Immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding two months 13. Chemotherapy in the preceding year 14. Major surgery in the preceding 2 months 15. Blood or blood product transfusion in the preceding 2 months |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Research Unit | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
CardioDx | Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline | up to 1 months |
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