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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

November 30, 2010
February 7, 2013
November 2010
February 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01251302 on ClinicalTrials.gov Archive Site
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Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern (IMPACT-CARD)
Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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

Angina or Anginal Equivalent
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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
200
June 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01251302
CDX 000011
No
CardioDx
CardioDx
Not Provided
Not Provided
CardioDx
February 2013

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