Coronary Artery Disease Clinical Trial
Official title:
Identification of Gene Expression Patterns in Circulating Cells That Predict the Presence of Coronary Artery Disease
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.
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.
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