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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
  Purpose
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.

Condition Intervention
Angina Pectoris Coronary Artery Disease Chest Pain Cardiovascular Diseases Coronary Heart Disease CAD CVD CHD Diagnostic Test: Corus CAD

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:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   None Retained
PaxGene tube for RNA collected

Enrollment: 171
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Diagnostic Test: Corus CAD
Age/Sex/Gene Expression Score
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.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251302


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
CardioDx
Investigators
Study Director: Michael Zapien, MS CardioDx, Inc.
  More Information

Publications:
Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01251302     History of Changes
Other Study ID Numbers: CDX_000011
IMPACT-CARD ( Other Identifier: CardioDx )
First Submitted: November 30, 2010
First Posted: December 1, 2010
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by CardioDx:
Corus CAD
Age/Sex/Gene Expression Score
Molecular Genetics
Atherosclerosis
ASGES
Gene Expression
GES
CAD
CVD
CHD
Clinical Utility
Precision Medicine
Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Disease
Coronary Heart Disease
IMPACT
IMPACT-CARD

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Chest Pain
Angina Pectoris
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms