Primary Care Providers Use of a Gene Expression Test in Coronary Artery Disease Diagnosis (IMPACT-PCP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01594411
First received: April 20, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

This is a prospective, multi-center study examining the clinical impact of the Corus® CAD 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
Chest Pain
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of a Molecular Personalized Coronary Gene Expression Test 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 Gene Expression Testing [ Time Frame: pre- and post- gene expression testing results (on avaerage 2-3 days to receive GES) ] [ Designated as safety issue: No ]
    The primary objective was to assess whether the Gene Expression Score (GES) 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 GES 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 GES ranging from 1 to 40. A score <=15 indicates a low risk of underlying obstructive coronary disease. The GES has a negative predictive value of 96% for GES <=15 in a popluation 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
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.

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 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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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 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
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: 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:
Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01594411     History of Changes
Other Study ID Numbers: IMPACT-PCP, CDX 000014
Study First Received: April 20, 2012
Results First Received: September 3, 2013
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by CardioDx:
Coronary Artery Disease
Chest Pain
Diagnosis of cardiovascular disease

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

ClinicalTrials.gov processed this record on September 22, 2014