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

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

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Chest Pain; Angina Pectoris; Coronary Heart Disease; CAD; CHD; CVD
• Intervention / Treatment: Diagnostic test: Corus CAD (ASGES)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Non-diabetic subjects will be enrolled at the Department of Cardiology, Mayo Clinic, Florida. Enrollment will not be randomized. Subjects will be enrolled based on achieving an equal number of men and women, and known Coronary Artery Disease or CAD (prior history of ischemia by stress test or a coronary catheterization documenting greater than or equal to 50% stenosis in any vessels within 12 months prior to enrollment) and no known CAD (controls - prior of history of coronary catheterization documenting less than or equal to 15% stenosis in any vessels within 12 months prior to enrollment). Enrollment will be stratified as shown below:

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline	up to 1 months

Collaborators and Investigators

• Sponsor: CardioDx
• Collaborators: Mayo Clinic

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Cardiovascular Disease; Atherosclerosis; Gene Expression; CHD; Precision Medicine; CAD; Coronary Heart Disease; Chest Pain; GES; CVD; Angina Pectoris; Corus CAD; ASGES; Age/Sex/Gene Expression Score; Exercise Stress Test; EXERCISE
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Chest Pain; Angina Pectoris
• Other Study ID Numbers: CDX_000012; Exercise (ABCSG)