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

March 16, 2012
February 18, 2014
April 2012
March 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01557855 on ClinicalTrials.gov Archive Site
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.
Same as current
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Investigation of a Novel Gene Expression Test for Diagnosis of Obstructive Coronary Artery Disease
Coronary Obstruction Detection by Molecular Personalized Gene Expression

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

Coronary Artery Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
342
May 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01557855
CDX_000013
No
CardioDx
CardioDx
Not Provided
Study Director: May Yau CardioDx
CardioDx
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP