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Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease (REGISTRY-I)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557855
First Posted: March 20, 2012
Last Update Posted: October 19, 2017
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.
Information provided by (Responsible Party):
CardioDx
March 16, 2012
March 20, 2012
October 19, 2017
April 2012
March 2013   (Final data collection date for primary outcome measure)
Rate of referral vs. Corus CAD (ASGES) score as continuous variables [ Time Frame: 30 Days ]
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.
Rate of referral vs. Corus score as continuous variables [ Time Frame: 30 Days ]
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.
Complete list of historical versions of study NCT01557855 on ClinicalTrials.gov Archive Site
Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores. [ Time Frame: 30 Day ]
composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days.
Rate of referral difference between low Corus (</=15) and non-low Corus (>15) scores. [ Time Frame: 30 Day ]
composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days.
Not Provided
Not Provided
 
Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease
Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.
The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) 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.

This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD score as continuous variables.

Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) 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 (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample
Subjects will be enrolled at multiple qualified participating study centers that have incorporated Corus CAD (ASGES) for the diagnosis of obstructive CAD into their routine practice.
  • Coronary Artery Disease
  • Angina Pectoris
  • Chest Pain
  • Cardiovascular Diseases
  • Coronary Heart Disease
  • CAD
  • CVD
  • CHD
Diagnostic Test: Corus CAD
Age/Sex/Gene Expression Score
Not Provided

*   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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01557855
CDX_000013
REGISTRY-I ( Other Identifier: CardioDx )
No
Not Provided
Not Provided
CardioDx
CardioDx
Not Provided
Study Director: Michael Zapien, MS CardioDx
CardioDx
October 2017