Status:
COMPLETED
Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test
Lead Sponsor:
CardioDx
Collaborating Sponsors:
Mayo Clinic
Conditions:
Coronary Artery Disease
Angina Pectoris
Eligibility:
All Genders
45-75 years
Brief Summary
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 esta...
Detailed Description
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 expre...
Eligibility Criteria
Inclusion
- Ages 45-75 years old
- Able to perform an adequate exercise stress test
- Subjects with no known CAD and subjects with known CAD subjects
Exclusion
- Known severe CAD that will be unsafe to exercise stress patient
- Current MI or high-risk acute coronary syndrome (including high-risk unstable angina
- NYHA class III or IV congestive heart failure
- Severe regurgitant or stenotic cardiac valvular lesion
- Severe left ventricular systolic dysfunction
- Active systemic infection in the preceding 2 months or chronic infection (e.g. HIV, Hepatitis B or C, Tuberculosis)\*\*.
- Protocol-specified rheumatologic, autoimmune or hematologic conditions
- 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.
- Total WBC 11,000/ul from a CBC drawn within 7 days of enrollment
- Inadequate exercise stress test.
- Recipient of any organ transplant
- Immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding two months
- Chemotherapy in the preceding year
- Major surgery in the preceding 2 months
- Blood or blood product transfusion in the preceding 2 months
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01486030
Start Date
September 1 2011
End Date
November 1 2013
Last Update
January 31 2019
Active Locations (1)
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1
Mayo Clinic Research Unit
Jacksonville, Florida, United States, 32224