Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test

Coronary Artery Disease Clinical Trial

— EXERCISE  

Official title:

Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD Diagnostic Test (Age, Sex, Gene Expression Score ASGES).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486030
• Other study ID #: CDX_000012
• Secondary ID: EXERCISE
• Status: Completed
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2019
• Source: CardioDx
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Angina Pectoris
• CAD
• Cardiovascular Diseases
• CHD
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• CVD
• Heart Diseases
• Myocardial Ischemia

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

External Links

•   Publication: Impact of Exercise Stress Testing on Diagnostic Gene Expression in Patients With Obstructive and Nonobstructive Coronary Artery Disease