Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making
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: 
      The purpose of this study is to understand the use of Corus CAD also known as Age/Sex/Gene
      Expression score (ASGES) in the clinical decision making process of patients who underwent
      the evaluation of chest pain or anginal equivalent symptoms. Specifically, to better
      understand whether the use of the assay in clinical decision making resulted in changes in
      noninvasive diagnostic test ordering or diagnostic yield of additional tests ordered and/or
      invasive angiography.
    

Detailed description: 
      The UCU-CARD (Understanding Clinician Utility-Cardiology) study is a retrospective,
      matched-cohort evaluation of diagnostic testing in a community-based cardiology practice
      setting that used a personalized age, sex, and gene expression test during early work-up of
      patients with symptoms suggestive of obstructive CAD (http://www.clinicaltrials.gov,
      NCT02223286). The study measured the rates of advanced cardiac diagnostic testing after
      initial work-up, including stress testing with imaging, CTA, or ICA. Rates of advanced
      diagnostic testing for patients who received the age, sex, and gene expression test (ASGES)
      were compared with testing rates for matched historical controls (usual care). The study
      hypothesis was that incorporating the age, sex, and gene expression testing early in the
      diagnostic work-up pathway would permit the identification of patients for whom advanced
      diagnostic testing was not required, thereby avoiding unnecessary testing and enabling
      cardiologists to focus their diagnostic resources more efficiently.

      This single-center study was conducted at the North Phoenix Heart Center (Phoenix, AZ), a
      community-based group cardiology practice that receives patients on referral from primary
      care physicians and other specialists in the surrounding area. The practice incorporated age,
      sex, and gene expression testing into its diagnostic protocol beginning in June 2011. Data
      collection was completed in December 2013. Institutional Review Board (IRB) approval of the
      study protocol was granted by Quorum Review. Informed consent waivers were granted as data
      collection was retrospective and all data were de-identified.
    

Intervention name(s): Corus CAD
Intervention type(s): Diagnostic Test
Intervention description(s): Age/Sex/Gene Expression Score
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population of interest and the main inclusion criterion for inclusion is the
        occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD
        or a history of prior myocardial infarction, and the utilization of Corus CAD (Age/Sex/Gene
        Expression score - ASGES).

        Additionally, subjects with similar chest pain (or angina equivalent) whom did not undergo
        Corus CAD (ASGES) will be included as a control group, to understand the diagnostic
        evaluation and management of patients prior to Corus CAD (ASGES) use.
      
Keywords: Corus CAD; ASGES; Age/Sex/Gene Expression Score; Gene Expression; GES; CAD; CVD; CHD; Precision Medicine; Clinical Utility; Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Disease; Coronary Heart Disease; UCU-CARD