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|
- 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.
|Study Start Date:||April 2012|
|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 coronary artery disease (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 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594411
|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|