Personalized Risk Evaluation and Diagnosis (Using Corus CAD or ASGES) in the Coronary Tree



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 99
Updated:2/2/2019
Start Date:July 2007
End Date:September 2011

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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.

Inclusion Criteria:

- Referral for a coronary angiogram (either invasive X-ray angiography or coronary CTA)

- Any one of the following clinical syndromes:

1. chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial
ischemia

2. low-risk unstable angin, or

3. asymptomatic individuals with a high probability of CAD

Exclusion Criteria:

- History of myocardial infarction or known CAD

- Current Myocardial Infarct (MI), acute coronary syndrome with high-risk features or
unstable angina with high-risk features

- New York Heart Association (NYHA) class III or IV congestive

- Inability to give informed congestive heart failures

- Severe left ventricular systolic dysfunction (LVEF<35%)

- Severe regurgitant or stenotic cardiac valve lesion

- Active or chronic systemic infection

- Rheumatologic, autoimmune or hematologic conditions

- Any organ transplant

- Immunosuppressive therapy

- Chemotherapy in the preceding year

- Major blood or blood product transfusion in the preceding 2 months
We found this trial at
10
sites
9888 Genesee Avenue
La Jolla, California 92037
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Pittsburgh, Pennsylvania 15212
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Anchorage, Alaska 99508
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1968 Peachtree Road Northwest
Atlanta, Georgia 30309
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414 North Camden Drive
Beverly Hills, California 90210
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Beverly Hills, CA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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Salt Lake City, Utah 84143
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106 Irving Street Northwest
Washington, District of Columbia 20010
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Washington,
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