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

January 29, 2019 updated by: CardioDx

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

4350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Heart Institute
    • California
      • Beverly Hills, California, United States, 90210
        • CV Medical Group Southern California
      • La Jolla, California, United States, 92037
        • Scripps Healthcare
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Fuqua Heart Center of Atlanta
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Intermountain Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing clinically indicated invasive coronary artery angiogram or CT angiogram.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
segment 1
Gene discovery blood draw
Diagnostic test: Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES
sement 2
Assay development blood draw
Diagnostic test: Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES
segment 3
Assay validation blood draw
Diagnostic test: Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES
segment 4
Additional assay testing blood draw (Note: post discovery diabetic subjects assigned to this group)
Diagnostic test: Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algorithm AUC >0.50
Time Frame: 30days
The primary analysis will be performed during the third segment of the study using a subset of the enrolled subjects ("primary subjects"). 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).
30days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioDx

Investigators

  • Study Chair: Mark Monane, MD FACP CMQ, CardioDx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria

July 11, 2007

First Posted (Estimate)

July 13, 2007

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX_000004
  • PREDICT (CardioDx)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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