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PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis (IMPACT-PCP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594411
First Posted: May 9, 2012
Last Update Posted: November 17, 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
This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.

Condition Intervention
Chest Pain Cardiovascular Diseases Angina Pectoris Coronary Artery Disease CAD CVD CHD Coronary Heart Disease 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 (Corus CAD or ASGES) on Primary Care Practice Pattern

Resource links provided by NLM:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score [ Time Frame: pre- and post- gene expression testing results (on average 2-3 days to receive ASGES) ]
    The primary objective was to assess whether the Age/Sex/Gene Expression Score (ASGES) altered clinicians' evaluations, defined by a change in patient management from preliminary to final decision. The change was prospectively defined as a downgrade or upgrade in intensity of the diagnostic plan based on the following hierarchical categories:(1) no further cardiac testing or treatment, (2) lifestyle changes or medical therapy, (3) stress testing (with or without imaging) or computed tomography/coronary angiography, or (4) invasive coronary angiography. The ASGES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. The changes in gene expression are quantified using an algorithm that generates a ASGES ranging from 1 to 40. A score <=15 indicates a low risk of underlying obstructive coronary disease. The ASGES has a negative predictive value of 96% for ASGES <=15 in a population referred to myocardial perfusion imaging.


Biospecimen Retention:   Samples Without DNA
One 2.5 mL PAXgene (PreAnalytiXTM) (for RNA preservation) tube will be filled with approximately 7.5 ml of blood and sent to CardioDx, Inc. for analysis.

Enrollment: 251
Study Start Date: April 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All subjects
Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant coronary artery disease (CAD) or a history of prior myocardial infarction.
Diagnostic Test: Corus CAD
Age/Sex/Gene Expression Score

Detailed Description:

In symptomatic patients with or without prior cardiac testing, the PCP will initially decide the subject's pretest probability for coronary artery disease (CAD) based on the subject's risk factors and quality of chest pain (typical or atypical), or anginal equivalent (e.g., jaw, arm pain, or unexplained shortness of breath) and consider the results of prior testing, if applicable. The initial questionnaire will capture the PCP's initial clinical impression and decision ('preliminary decision') on how to further evaluate and manage the patient. A Corus CAD (Age/Sex/Gene Expression score - ASGES) assay will be performed at the PCP's office. After the PCP has received the Corus CAD result (approximately 2-3 days later), the PCP will decide on the appropriate evaluation and management of the patient ('final decision') using the Corus CAD result in conjunction with his/her clinical impression and/or other clinical data available. The primary aim of this study is to evaluate whether the Corus CAD test results is associated with a change in the PCPs' diagnostic evaluation and management of patients as compared to their initial testing and treatment decisions.

Since it takes approximately two days for the physician to receive the result of the Corus CAD, symptomatic subjects with unstable angina, or suspicion for myocardial infarction will be excluded from the study.

A follow-up phone call and a detailed questionnaire will be performed at 30 + 15 days, from the time of blood draw, to assess the triage decision, such as referral to any subspecialists (cardiologist, gastroenterologist, and pulmonologist), cardiac diagnostic tests performed, cardiac procedures performed, and results of these cardiac tests and procedures.

  Eligibility

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) 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 infarction (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 :

    • Diabetes
    • Suspected unstable angina
    • Systemic infections
    • Systemic inflammatory conditions
  6. Any individuals currently taking:

    • Steroids
    • Immunosuppressive agents
    • Chemotherapeutic agents
  7. Any Major Surgery within 2 months
  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): NCT01594411


Locations
United States, Georgia
John's Creek Primary Care
Suwanee, Georgia, United States, 30024
United States, Louisiana
The Lipid Center
Baton Rouge, Louisiana, United States, 70809
United States, North Carolina
Carolina Family Healthcare
Charlotte, North Carolina, United States, 28277
United States, Texas
Family Care Clinic
Bonham, Texas, United States, 75418
Sponsors and Collaborators
CardioDx
Investigators
Study Director: May Yau, MS CardioDx
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01594411     History of Changes
Other Study ID Numbers: CDX_000014
IMPACT-PCP ( Other Identifier: CardioDx )
First Submitted: April 20, 2012
First Posted: May 9, 2012
Results First Submitted: September 3, 2013
Results First Posted: April 23, 2014
Last Update Posted: November 17, 2017
Last Verified: October 2017

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

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