PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis (IMPACT-PCP)
|ClinicalTrials.gov Identifier: NCT01594411|
Recruitment Status : Completed
First Posted : May 9, 2012
Results First Posted : April 23, 2014
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment|
|Chest Pain Cardiovascular Diseases Angina Pectoris Coronary Artery Disease CAD CVD CHD Coronary Heart Disease||Diagnostic Test: Corus CAD|
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 (Age/Sex/Gene Expression score - ASGES) assay will be performed at the PCP's office. After the PCP has received the Corus CAD (ASGES) 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 (ASGES) 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 (ASGES) 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 (ASGES), 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.
|Study Type :||Observational|
|Actual Enrollment :||251 participants|
|Official Title:||Investigation of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Primary Care Practice Pattern|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||February 2013|
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.
Diagnostic Test: Corus CAD
Age/Sex/Gene Expression Score (ASGES)
- Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score [ Time Frame: pre- and post- gene expression testing results (on average 2-3 days to receive ASGES) ]The primary objective was to assess whether the Age/Sex/Gene Expression Score (ASGES) 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 ASGES 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 ASGES ranging from 1 to 40. A score <=15 indicates a low risk of underlying obstructive coronary disease. The ASGES has a negative predictive value of 96% for ASGES <=15 in a population referred to myocardial perfusion imaging.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|