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

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ClinicalTrials.gov Identifier: NCT00500617
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
CardioDx

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Angina Pectoris Chest Pain Cardiovascular Diseases Coronary Heart Disease CAD CVD CHD Diagnostic Test: Corus CAD (ASGES)

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
Actual Enrollment : 4350 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Identification of Gene Expression Patterns in Circulating Cells That Predict the Presence of Coronary Artery Disease
Study Start Date : July 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples With DNA
whole blood, buffy coat, spun plasma, RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing clinically indicated invasive coronary artery angiogram or CT angiogram.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500617


Locations
United States, Alaska
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
United States, California
CV Medical Group Southern California
Beverly Hills, California, United States, 90210
Scripps HealthCare
La Jolla, California, United States, 92037
United States, District of Columbia
Washington Hospital Medical Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Fuqua Heart Center of Atlanta
Atlanta, Georgia, United States, 30309
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Allegheny Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Utah
Intermountain HealthCare
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
CardioDx
Investigators
Study Chair: Mark Monane, MD FACP CMQ CardioDx

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT00500617     History of Changes
Other Study ID Numbers: CDX_000004
PREDICT ( Other Identifier: CardioDx )
First Posted: July 13, 2007    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Keywords provided by CardioDx:
Atherosclerosis
Biological Markers
Molecular Genetics
Gene Expression
GES
CAD
CVD
CHD
Clinical Validity
Precision Medicine
ASGES
CT Angiography
Corus CAD
Coronary angiorgram
Age/Sex/Gene expression Score
Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Disease
Coronary Heart Disease
CTA
PREDICT

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Chest Pain
Angina Pectoris
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms