Angina Pectoris, CAD, Cardiovascular Diseases, CHD, Chest Pain, Coronary Artery Disease, Coronary Heart Disease, CVD
Conditions
Keywords
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
Brief 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).
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.
Interventions
DIAGNOSTIC_TESTCorus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES
Sponsors
Mayo Clinic
CardioDx
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline | up to 1 months |
Countries
United States
Outcome results
None listed