Primary Care Providers Use of a Gene Expression Test in Coronary Artery Disease Diagnosis (IMPACT-PCP)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Investigation of a Molecular Personalized Coronary Gene Expression Test on Primary Care Practice Pattern|
- 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.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||February 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
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.
|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|
|Study Director:||May Yau, MS||CardioDx|