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: December 3, 2014
Last verified: December 2014

November 30, 2010
December 3, 2014
November 2010
February 2012   (final data collection date for primary outcome measure)
  • Change in management practice pattern between preliminary and after Corus™ CAD decision [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]

    Change in management pattern comparing the preliminary and after Corus™ CAD decision 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
  • Change in management practice pattern between after Corus™ CAD decision and historical cohort. [ Time Frame: up to 195 days ] [ Designated as safety issue: No ]

    Change in management pattern comparing the Corus™ CAD driven decision and the historical cohort ill 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
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
Complete list of historical versions of study NCT01251302 on ClinicalTrials.gov Archive Site
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Not Provided
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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 a gene expression score blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.

A prospective cohort of 88 subjects receiving the gene expression score assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

PaxGene tube for RNA collected

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 Pectoris
  • Coronary Artery Disease
Other: Gene Expression Score (GES)
The gene expression score is a validated, quantitative blood-based diagnostic test measuring peripheral blood cell expression levels for 23 genes to determine the likelihood of obstructive coronary artery disease (at least one vessel with >=50% angiographic coronary artery stenosis)
Other Name: Corus CAD
  • Prospective Cohort
    Patient presenting with chest pain or anginal equivalent and receiving a resulted gene expression score (GES) to assist in diagnosis.
    Intervention: Other: Gene Expression Score (GES)
  • Retrospective Cohort
    Patients presenting with chest pain or anginal equivalent who did not receive a gene expression score (GES) to assist in diagnosis. Note: this cohort was historical.
McPherson JA, Davis K, Yau M, Beineke P, Rosenberg S, Monane M, Fredi JL. The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery disease: results from the IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial. Crit Pathw Cardiol. 2013 Jun;12(2):37-42. doi: 10.1097/HPC.0b013e3182822bd0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
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 myocardial infarct (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
Study Director: Michael Zapien, MS CardioDx, Inc.
CardioDx
December 2014

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