Coronary Obstruction Detection by Molecular Personalized Gene Expression (Corus CAD or ASGES)
Condition: Coronary Artery Disease; Chest Pain; Cardiovascular Diseases; Coronary Heart Disease; Angina Pectoris; CAD; CVD; CHD
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Angina Pectoris; Chest Pain
Study type: Observational

Summary: 
      To validate the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay in
      subjects who are referred for the work-up of coronary artery disease. The study will evaluate
      the clinical utility of a gene expression test Corus CAD (Age, Sex, Gene Expression Score -
      ASGES) in subjects referred for myocardial perfusion imaging (MPI) work-up for suspected
      obstructive atherosclerotic coronary artery disease (CAD). The Corus CAD (ASGES) is a gene
      expression test that quantify the expression of multiple genes from circulating peripheral
      blood cells to detect the presence of clinically significant obstructive CAD in patients with
      chest pain.
    

Detailed description: 
      This prospective, multicenter study obtained peripheral blood samples for gene expression
      score (GES) before MPI in 537 consecutive patients Patients with abnormal MPI usually
      underwent invasive coronary angiography; all others had research coronary computed
      tomographic angiography, with core laboratories defining coronary anatomy A total of 431
      patients completed GES, coronary imaging (invasive coronary angiography or computed
      tomographic angiography), and MPI Mean age was 56±10 years (48% women) The prespecified
      primary end point was GES receiver-operating characteristics analysis to discriminate ≥50%
      stenosis (15% prevalence by core laboratory analysis) Area under the receiver-operating
      characteristics curve for GES was 0 79 (95% confidence interval, 0 73-0 84; P<0 001), with
      sensitivity, specificity, and negative predictive value of 89%, 52%, and 96%, respectively,
      at a prespecified threshold of ≤15 with 46% of patients below this score The GES outperformed
      clinical factors by receiver-operating characteristics and reclassification analysis and
      showed significant correlation with maximum percent stenosis. Six-month follow-up on 97% of
      patients showed that 27 of 28 patients with adverse cardiovascular events or
      revascularization had GES >15 Site and core-laboratory MPI had areas under the curve of 0 59
      and 0 63, respectively, significantly less than GES.
    

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: 
        The study will enroll a patient population that presents with stable chest pain syndrome or
        anginal equivalent and referred for stress myocardial profusion imaging.
      
Biospecimen description: 
      RNA PAXgene
    
Keywords: Angina Pectoris; Myocardial Ischemia; Molecular Genetics; Atherosclerosis; Corus CAD; ASGES; Age/Sex/Gene Expression Score; Gene Expression; GES; CAD; CVD; CHD; Precision Medicine; Clinical Validity; Myocardial Perfusion Imaging; Coronary Artery Disease; Chest Pain; Cardiovascular Disease; Coronary Heart Disease; MPI; COMPASS