Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test (EXERCISE)
This study has been completed.
Information provided by (Responsible Party):
First received: October 17, 2011
Last updated: November 25, 2014
Last verified: November 2014
Acute exercise such as in exercise stress test would affect the peripheral gene expression levels of the 23 genes in the CORUS CAD algorithm and the time frame.
||Observational Model: Cohort
Time Perspective: Prospective
||Effect of Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test
Biospecimen Retention: Samples With DNA
Primary Outcome Measures:
- Gene expression score difference between peak exercise and baseline [ Time Frame: up to 1 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
Pilot study, investigates the effects of "acute" exercise on PGE levels as measured by CORUS CAD score.
|Ages Eligible for Study:
||45 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Acute exercise, exercise stress test affect the peripheral gene expression levels of the 23 genes in the CORUS CAD algorithm and the time frame at which, gene levels change.
- Ages 45-75 years old
- Able to perform an adequate exercise stress test
- Subjects with no known CAD and subjects with known CAD subjects
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01486030
|Mayo Clinic Research Unit
|Jacksonville, Florida, United States, 32224 |
||Michael Zapien, MS
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 17, 2011
||November 25, 2014
||United States: Institutional Review Board
Keywords provided by CardioDx:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 30, 2015
Coronary Artery Disease
Arterial Occlusive Diseases