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
  Purpose

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.


Condition Intervention
Angina Pectoris
Coronary Artery Disease
Other: Gene Expression Score (GES)

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 ] [ 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


Biospecimen Retention:   Samples With DNA

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 gene expression score (GES) to assist in diagnosis.
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
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.

Detailed Description:

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.

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Study First Received: November 30, 2010
Last Updated: December 3, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 26, 2015