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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01594411
First received: April 20, 2012
Last updated: February 7, 2013
Last verified: February 2013
  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:
  • The primary endpoint is to assess whether the use of the Corus® CAD test has an effect on the PCP's evaluation and management of the patient as defined by a change* of management pattern between the preliminary versus final decision. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    *Change equals the number of patients with evaluation and management downgraded or upgraded [in hierarchical order]: 1) no further cardiac testing or treatment, 2) medical therapy for angina or noncardiac chest pain or lifestyle changes, 3) stress testing with or without imaging or CT angiography, or 4) invasive cardiac catheterization between the preliminary and final decision.


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.


Estimated Enrollment: 250
Study Start Date: April 2012
Estimated 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 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 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 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
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

No publications provided

Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01594411     History of Changes
Other Study ID Numbers: IMPACT-PCP, CDX 000014
Study First Received: April 20, 2012
Last Updated: February 7, 2013
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
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Pain
Signs and Symptoms
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014