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
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test

Resource links provided by NLM:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • Gene expression score difference between peak exercise and baseline [ Time Frame: up to 1 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

RNA PAXgene


Enrollment: 20
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486030

Locations
United States, Florida
Mayo Clinic Research Unit
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
CardioDx
Mayo Clinic
Investigators
Study Director: May Yau CardioDx
  More Information

No publications provided

Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01486030     History of Changes
Other Study ID Numbers: CDX_000012
Study First Received: October 17, 2011
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by CardioDx:
Atherosclerosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014