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
2 other identifiers
observational
251
1 country
4
Brief Summary
This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 20, 2012
CompletedFirst Posted
Study publicly available on registry
May 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
April 23, 2014
CompletedJanuary 31, 2019
January 1, 2019
9 months
April 20, 2012
September 3, 2013
January 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score
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.
pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)
Study Arms (1)
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.
Interventions
Eligibility Criteria
This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) 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.
You may qualify if:
- Stable chest pain, typical or atypical angina or anginal equivalent
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioDxlead
Study Sites (4)
John's Creek Primary Care
Suwanee, Georgia, 30024, United States
The Lipid Center
Baton Rouge, Louisiana, 70809, United States
Carolina Family Healthcare
Charlotte, North Carolina, 28277, United States
Family Care Clinic
Bonham, Texas, 75418, United States
Related Publications (2)
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.
PMID: 24610188RESULTLadapo 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.
PMID: 25828395DERIVED
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Prospective design may have influenced the diagnostic strategy; but historical controls had a similar diagnostic strategy. Possible Selection bias; we believe these pts are typical of each practice. Appropriateness of care not evaluated
Results Point of Contact
- Title
- EJ Fernandez, MD, CCRP - Sr. Manager Clinical Affairs
- Organization
- CardioDx, Inc.
Study Officials
- STUDY DIRECTOR
May Yau, MS
CardioDx
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2012
First Posted
May 9, 2012
Study Start
April 1, 2012
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
January 31, 2019
Results First Posted
April 23, 2014
Record last verified: 2019-01