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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01486030
Other study ID # CDX_000012
Secondary ID EXERCISE
Status Completed
Phase
First received
Last updated
Start date September 2011
Est. completion date November 2013

Study information

Verified date January 2019
Source CardioDx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective, single-center study that aims to evaluate the acute and delayed effect of exercise stress testing on the peripheral gene expression (PGE) levels using a predefined gene set established in the Corus CAD (Age/Sex/Gene Expression score - ASGES) test in subject with known obstructive coronary artery disease (CAD) and in control subjects (without known CAD).


Description:

This is a prospective, single-center study. This protocol is a pilot study to investigate the effects of "acute" exercise (by exercise stress testing; modified Bruce protocol) on peripheral gene expression (PGE) levels as measured by Corus CAD score (Age/Sex/Gene Expression score - ASGES). Subjects will have blood sampling at baseline, at peak exercise, within 30 to 60 minutes post-exercise, at 24-36 hours post-exercise. The study will be stratified by presence of CAD and gender. An equal number of subjects with known CAD and normal controls will be enrolled. Equally, an equal number of men and women will be included. A screening CBC and HgbA1c will be performed to ensure the subject meets the intended use instruction for Corus CAD (ASGES). Data collection will include presence or absence of ECG ischemia with testing, as well as heart rate and blood pressure response to exercise with other ECG and dynamic variables. There will be four blood samples taken per subject as shown in the figure below.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES

Locations

Country Name City State
United States Mayo Clinic Research Unit Jacksonville Florida

Sponsors (2)

Lead Sponsor Collaborator
CardioDx Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline up to 1 months
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