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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00500617
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
CardioDx

Tracking Information
First Submitted Date July 11, 2007
First Posted Date July 13, 2007
Last Update Posted Date January 31, 2019
Study Start Date July 2007
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2014)
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).
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Personalized Risk Evaluation and Diagnosis (Using Corus CAD or ASGES) in the Coronary Tree
Official Title Identification of Gene Expression Patterns in Circulating Cells That Predict the Presence of Coronary Artery Disease
Brief 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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, buffy coat, spun plasma, RNA
Sampling Method Probability Sample
Study Population Patients undergoing clinically indicated invasive coronary artery angiogram or CT angiogram.
Condition
  • Coronary Artery Disease
  • Angina Pectoris
  • Chest Pain
  • Cardiovascular Diseases
  • Coronary Heart Disease
  • CAD
  • CVD
  • CHD
Intervention Diagnostic Test: Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES
Study Groups/Cohorts
  • segment 1
    Gene discovery blood draw
    Intervention: Diagnostic Test: Corus CAD (ASGES)
  • sement 2
    Assay development blood draw
    Intervention: Diagnostic Test: Corus CAD (ASGES)
  • segment 3
    Assay validation blood draw
    Intervention: Diagnostic Test: Corus CAD (ASGES)
  • segment 4
    Additional assay testing blood draw (Note: post discovery diabetic subjects assigned to this group)
    Intervention: Diagnostic Test: Corus CAD (ASGES)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 25, 2014)
4350
Original Estimated Enrollment
 (submitted: July 11, 2007)
1500
Actual Study Completion Date September 2011
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00500617
Other Study ID Numbers CDX_000004
PREDICT ( Other Identifier: CardioDx )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CardioDx
Study Sponsor CardioDx
Collaborators Not Provided
Investigators
Study Chair: Mark Monane, MD FACP CMQ CardioDx
PRS Account CardioDx
Verification Date January 2019