Personalized Risk Evaluation and Diagnosis In the Coronary Tree (PREDICT)

This study has been terminated.
(Primary endpoint reached. Additional patients not required. Discovery, development and validation patient cohorts/segments completed and analyzed)
Sponsor:
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT00500617
First received: July 11, 2007
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

Atherosclerotic coronary artery disease (CAD) is the most common cause of morbidity and mortality worldwide. CAD is precipitated by a complex interaction of genetic and environmental factors. Establishing the diagnosis of CAD before a myocardial infarction or death is critically important. However, the diagnosis of CAD can be a significant challenge, and current non-invasive modalities often yield indeterminate results.

There are several biologically based theories of atherogenesis related to plaque development in arterial walls. The aim of this study is to identify genetic and biological markers that distinguish patients with CAD.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by CardioDx:

Primary Outcome Measures:
  • Algorithm AUC >0.50 [ Time Frame: 30days ] [ Designated as safety issue: No ]
    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


Enrollment: 4150
Study Start Date: July 2007
Study Completion Date: September 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-Diabetic
Diabetic

Detailed Description:

The purpose of the PREDICT study is to develop and validate a diagnostic blood Assay for atherosclerotic coronary artery disease (CAD). The Assay 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: gene discovery (segment 1), Assay development (segment 2), Assay validation (segment 3), and additional Assay 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 Assay. 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 Assay 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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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 MI, acute coronary syndrome with high-risk features or unstable angina with high-risk features
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
LaJolla, 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
  More Information

No publications provided by CardioDx

Additional 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
Study First Received: July 11, 2007
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by CardioDx:
Atherosclerosis
Biological Markers
Molecular Genetics

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014