Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test (EXERCISE)
This study is currently recruiting participants.
Verified February 2013 by CardioDx
Sponsor:
CardioDx
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01486030
First received: October 17, 2011
Last updated: February 7, 2013
Last verified: February 2013
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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
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 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.
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:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486030
Contacts
| Contact: May Yau | 650-475-2745 | myau@cardiodx.com |
Locations
| United States, Florida | |
| Mayo Clinic Research Unit | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Gerald Fletcher, MD | |
| Contact: Barbara Little, RN | |
Sponsors and Collaborators
CardioDx
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: | February 7, 2013 |
| 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 May 22, 2013