Investigation of a Novel Gene Expression Test for Diagnosis of Obstructive Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01557855
First received: March 16, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

The objective of this study is to collect data on the commercial use of CORUS® (validated quantitative in vitro diagnostic test) Coronary Artery Disease (CAD) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' CORUS Score, and to better understand patient management patterns for clinicians ordering the test.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coronary Obstruction Detection by Molecular Personalized Gene Expression

Resource links provided by NLM:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • Rate of referral vs. Corus score as continuous variables [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days.


Secondary Outcome Measures:
  • Rate of referral difference between low Corus (</=15) and non-low Corus (>15) scores. [ Time Frame: 30 Day ] [ Designated as safety issue: No ]
    composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days.


Enrollment: 342
Study Start Date: April 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Objective of the study is to assess whether the score provided by the CORUS® CAD test has an effect on the Primary Care Physician's patient management and referral patterns once received:

  1. no further cardiac testing or treatment
  2. medical therapy for angina or non-cardiac chest pain
  3. Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.

Since it takes approximately two days for the physician to receive the result of the CORUS CAD, initial diagnostic testing will reflect local standard of care

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects will be enrolled at multiple qualified participating study centers that have incorporated CORUS CAD for the diagnosis of obstructive CAD into their routine practice.

Criteria

Inclusion Criteria:

  1. Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
  2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

  1. History of myocardial infarction
  2. Current MI or acute coronary syndrome
  3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
  4. Any previous coronary Revascularization
  5. Any individuals with:

    • Diabetes
    • Suspected unstable angina
    • Systemic infections
    • Systemic inflammatory conditions
  6. Any individuals currently taking:

    • Steroids
    • Immunosuppressive agents
    • Chemotherapeutic agents
  7. Recipient of any organ transplant
  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: NCT01557855

Locations
United States, Arizona
Arizona Sun Family Medicine
Gilbert, Arizona, United States, 85296
Fiel Family Medicine
Tempe, Arizona, United States, 85283
United States, Georgia
Town Lake Internal Medicine
Woodstock, Georgia, United States, 30189
United States, Louisiana
Maringouin Medical Center
Maringouin, Louisiana, United States, 70757
The Bonin Clinic
Zachary, Louisiana, United States, 70791
United States, North Carolina
Triangle Primary Care
Wake Forest, North Carolina, United States, 27587
United States, Ohio
Comprehensive Physicians Associates
Youngstown, Ohio, United States, 44505
Sponsors and Collaborators
CardioDx
Investigators
Study Director: May Yau CardioDx
  More Information

No publications provided

Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01557855     History of Changes
Other Study ID Numbers: CDX_000013
Study First Received: March 16, 2012
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014