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

April 20, 2012
February 7, 2013
April 2012
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01594411 on ClinicalTrials.gov Archive Site
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Primary Care Providers Use of a Gene Expression Test in Coronary Artery Disease Diagnosis
Investigation of a Molecular Personalized Coronary Gene Expression Test on Primary Care Practice Pattern

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Probability Sample

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.

  • Chest Pain
  • Cardiovascular Disease
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
February 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01594411
IMPACT-PCP, CDX 000014
No
CardioDx
CardioDx
Not Provided
Study Director: May Yau, MS CardioDx
CardioDx
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP