We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern (IMPACT-CARD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01251302
First Posted: December 1, 2010
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
November 30, 2010
December 1, 2010
October 19, 2017
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 ]

    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 ]

    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 ]

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
Not Provided
Not Provided
Not Provided
Not Provided
 
Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern
Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern
To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) 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 Corus CAD (Age/Sex/Gene Expression score - ASGES) 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:   None Retained
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
  • Chest Pain
  • Cardiovascular Diseases
  • Coronary Heart Disease
  • CAD
  • CVD
  • CHD
Diagnostic Test: Corus CAD
Age/Sex/Gene Expression Score
  • Prospective Cohort
    Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis.
    Intervention: Diagnostic Test: Corus CAD
  • Retrospective Cohort
    Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) 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
Sexes Eligible for Study: All
21 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01251302
CDX_000011
IMPACT-CARD ( Other Identifier: CardioDx )
No
Not Provided
Not Provided
CardioDx
CardioDx
Not Provided
Study Director: Michael Zapien, MS CardioDx, Inc.
CardioDx
October 2017