Personalized Risk Evaluation and Diagnosis In the Coronary Tree (PREDICT)

• Algorithm AUC >0.50 [ Time Frame: 30days ] [ Designated as safety issue: No ]
  The primary endpoint for the PREDICT study is a validated algorithm that can accurately classify subjects with and without any coronary artery lesion with a ≥50% diameter stenosis, as measured by Core Laboratory blinded quantitative coronary angiography. In evaluating this endpoint, subjects will be classified as either cases or controls. The endpoint will be assessed by calculating the area under the curve (AUC) for the algorithm score, and testing against an AUC = 0.50 to determine clinical utility, using an alpha level of 0.05 (two-sided).
  
  

The purpose of the PREDICT study is to develop and validate a diagnostic blood Assay for atherosclerotic coronary artery disease (CAD). The Assay 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: gene discovery (segment 1), Assay development (segment 2), Assay validation (segment 3), and additional Assay 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 Assay. 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 Assay 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.