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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486030
First Posted: December 6, 2011
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
CardioDx
  Purpose
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).

Condition Intervention
Coronary Artery Disease Angina Pectoris Chest Pain Cardiovascular Diseases Coronary Heart Disease CAD CVD CHD Diagnostic Test: Corus CAD

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 (Age, Sex, Gene Expression Score ASGES).

Resource links provided by NLM:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline [ Time Frame: up to 1 months ]

Biospecimen Retention:   Samples With DNA
RNA PAXgene

Enrollment: 20
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Diagnostic Test: Corus CAD
    Age/Sex/Gene Expression Score
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486030


Locations
United States, Florida
Mayo Clinic Research Unit
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
CardioDx
Mayo Clinic
Investigators
Study Director: Michael Zapien, MS CardioDx
  More Information

Additional Information:
Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01486030     History of Changes
Other Study ID Numbers: CDX_000012
EXERCISE ( Other Identifier: CardioDx )
First Submitted: October 17, 2011
First Posted: December 6, 2011
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by CardioDx:
Atherosclerosis
Corus CAD
Age/Sex/Gene Expression Score
ASGES
Gene Expression
GES
CAD
CVD
CHD
Precision Medicine
Exercise Stress Test
Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Disease
Coronary Heart Disease
EXERCISE

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Chest Pain
Angina Pectoris
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms