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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 February 2013 |
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Main ID: |
NCT01486030 |
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Date of registration:
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17/10/2011 |
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Primary sponsor: |
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Public title:
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Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test
EXERCISE |
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Scientific title:
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Effect of Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01486030 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Gerald Fletcher, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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May Yau |
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Address:
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Telephone:
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650-475-2745 |
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Email:
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myau@cardiodx.com |
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Affiliation:
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Name:
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May Yau |
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Address:
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Telephone:
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Email:
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Affiliation:
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CardioDx |
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Key inclusion & exclusion criteria
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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
Age minimum:
45 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Primary Outcome(s)
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Gene expression score difference between peak exercise and baseline
[Time Frame: up to 1 months]
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Secondary ID(s)
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CDX_000012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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