Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test
Condition: Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Diseases; Coronary Heart Disease; CAD; CVD; CHD
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Angina Pectoris; Chest Pain
Study type: Observational

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.
    

Intervention name(s): Corus CAD (ASGES)
Intervention type(s): Diagnostic Test
Intervention description(s): Age/Sex/Gene Expression Score - ASGES
Observational model: Cohort
Time perspective: Prospective
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:
      
Biospecimen description: 
      RNA PAXgene
    
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