Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test (EXERCISE)

This study has been completed.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01486030
First received: October 17, 2011
Last updated: January 28, 2014
Last verified: January 2014

October 17, 2011
January 28, 2014
September 2011
November 2013   (final data collection date for primary outcome measure)
Gene expression score difference between peak exercise and baseline [ Time Frame: up to 1 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01486030 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test
Effect of Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test

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.

Pilot study, investigates the effects of "acute" exercise on PGE levels as measured by CORUS CAD score.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

RNA PAXgene

Probability Sample

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.

Coronary Artery Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01486030
CDX_000012
No
CardioDx
CardioDx
Mayo Clinic
Study Director: May Yau CardioDx
CardioDx
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP