- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594411
PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis (IMPACT-PCP)
Investigation of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Primary Care Practice Pattern
Study Overview
Status
Conditions
Intervention / Treatment
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 (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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Suwanee, Georgia, United States, 30024
- John's Creek Primary Care
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- The Lipid Center
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North Carolina
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Charlotte, North Carolina, United States, 28277
- Carolina Family Healthcare
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Texas
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Bonham, Texas, United States, 75418
- Family Care Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Stable chest pain, typical or atypical angina or anginal equivalent
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.
Exclusion Criteria:
- History of myocardial infarction
- Current Myocardial infarction (MI) or acute coronary syndrome.
- Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms.
- Any previous coronary revascularization.
Any individuals with :
- Diabetes
- Suspected unstable angina
- Systemic infections
- Systemic inflammatory conditions
Any individuals currently taking:
- Steroids
- Immunosuppressive agents
- Chemotherapeutic agents
- Any Major Surgery within 2 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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 coronary artery disease (CAD) or a history of prior myocardial infarction.
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Age/Sex/Gene Expression Score (ASGES)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: May Yau, MS, CardioDx
Publications and helpful links
General Publications
- Herman L, Froelich J, Kanelos D, St Amant R, Yau M, Rhees B, Monane M, McPherson J. Utility of a genomic-based, personalized medicine test in patients presenting with symptoms suggesting coronary artery disease. J Am Board Fam Med. 2014 Mar-Apr;27(2):258-67. doi: 10.3122/jabfm.2014.02.130155.
- Ladapo JA, Herman L, Weiner BH, Rhees B, Castle L, Monane M, McPherson JA. Use of a blood test incorporating age, sex, and gene expression influences medical decision-making in the evaluation of women presenting with symptoms suggestive of obstructive coronary artery disease: summary results from two ambulatory care studies in primary care. Menopause. 2015 Nov;22(11):1224-30. doi: 10.1097/GME.0000000000000443.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDX_000014
- IMPACT-PCP (Other Identifier: CardioDx)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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