Text Size

Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern (IMPACT-CARD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01251302
First received: November 30, 2010
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

To investigate whether the use of Corus CAD blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.


Condition
Angina or Anginal Equivalent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioDx:

Primary Outcome Measures:
  • To evaluate whether there is a change in management practice pattern after Corus™ CAD [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]

    Change in management pattern after Corus™ CAD will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:

    1. No further cardiac testing or treatment
    2. Medical therapy for angina or non-cardiac chest pain
    3. Stress testing with or without imaging
    4. CT angiography
    5. Invasive cardiac catheterization


Estimated Enrollment: 200
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
  Eligibility

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

The study will enroll a patient population that present with chest pain or anginal equivalent symptoms who are referred to a cardiologist for evaluation.

Criteria

Inclusion Criteria:

  1. Stable chest pain, typical or atypical angina or anginal 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:

    1. Diabetes
    2. Suspected unstable angina
    3. Systemic infections
    4. Systemic inflammatory conditions

  6. Any individuals currently taking:

    1. Steroids
    2. Immunosuppressive agents
    3. Chemotherapeutic agents
  7. Recipient of any organ transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251302

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
CardioDx
  More Information

No publications provided

Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01251302     History of Changes
Other Study ID Numbers: CDX 000011
Study First Received: November 30, 2010
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by CardioDx:
Coronary Artery Disease
Angina
Molecular Genetics
Atherosclerosis

ClinicalTrials.gov processed this record on May 23, 2013