Personalized Risk Evaluation and Diagnosis (Using Corus CAD or ASGES) in the Coronary Tree
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 PREDICT study is to develop and validate a diagnostic blood ASGES (age, sex, gene
      expression score) or Corus CAD for atherosclerotic coronary artery disease (CAD). The Corus
      CAD (Age/Sex/Gene Expression score - ASGES) will use quantitative real-time PCR (RT-PCR) to
      quantify the expression of multiple genes from circulating peripheral blood cells to assess
      the presence of clinically significant CAD in a patient.
    

Detailed description: 
      The purpose of the PREDICT study is to develop and validate a diagnostic blood ASGES (age,
      sex, gene expression score) or Corus CAD for atherosclerotic coronary artery disease (CAD).
      The Corus CAD (Age/Sex/Gene Expression score - ASGES) will use quantitative real-time PCR
      (RT-PCR) to quantify the expression of multiple genes from circulating peripheral blood cells
      to assess the presence of clinically significant CAD in a patient.

      This is a prospective, multi-center, observational study. Participation in the study does not
      alter clinical care. The only procedure required by the protocol is collection of a research
      blood sample. All other data collected will be in accordance with each participating
      institution's standard patient care.

      The study is divided into four sequential segments with unique subjects and goals: ASGES
      (Corus CAD) discovery (segment 1), ASGES (Corus CAD) development (segment 2), ASGES (Corus
      CAD) validation (segment 3), and additional ASGES (Corus CAD) testing (segment 4). The
      primary analysis will be performed during the third segment of the study using a subset of
      the enrolled subjects ("primary subjects"). Primary subjects will be defined by additional
      eligibility criteria beyond the general eligibility criteria required for enrollment in the
      overall study. The additional, post-enrollment eligibility criteria will be based on clinical
      and demographic factors that are found during the course of the study to affect the
      expression of genes used in the ASGES (Corus CAD). Such factors will be identified during
      gene discovery and algorithm development. The post-enrollment eligibility criteria will be
      defined prior to the beginning of the ASGES (Corus CAD) validation segment of the study.

      In addition, three substudies are planned and will enroll up to 1500 subjects.

        -  The first substudy will include subjects undergoing cardiac CT angiography (CTA) and
           aims to determine how gene expression correlates with total coronary atheroma burden, as
           measured by CTA.

        -  The second substudy examines sample handling and shipping conditions and does not affect
           the treatment of the subjects.

        -  The third substudy will focus on additional algorithm development and validation in a
           non-diabetic female patient population.
    

Intervention name(s): Corus CAD (ASGES)
Intervention type(s): Diagnostic Test
Intervention description(s): Age/Sex/Gene Expression Score - ASGES
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing clinically indicated invasive coronary artery angiogram or CT
        angiogram.
      
Biospecimen description: 
      whole blood, buffy coat, spun plasma, RNA
    
Keywords: Atherosclerosis; Biological Markers; Molecular Genetics; Gene Expression; GES; CAD; CVD; CHD; Clinical Validity; Precision Medicine; ASGES; CT Angiography; Corus CAD; Coronary angiorgram; Age/Sex/Gene expression Score; Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Disease; Coronary Heart Disease; CTA; PREDICT