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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 05, 2015
Coronary Artery Disease
Arterial Occlusive Diseases