Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease
REGISTRY-I
Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.
2 other identifiers
observational
342
1 country
7
Brief Summary
The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.
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
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2012
CompletedFirst Posted
Study publicly available on registry
March 20, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJanuary 31, 2019
January 1, 2019
11 months
March 16, 2012
January 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of referral vs. Corus CAD (ASGES) score as continuous variables
Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days.
30 Days
Secondary Outcomes (1)
Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores.
30 Day
Interventions
Age/Sex/Gene Expression Score - ASGES
Eligibility Criteria
Subjects will be enrolled at multiple qualified participating study centers that have incorporated Corus CAD (ASGES) for the diagnosis of obstructive CAD into their routine practice.
You may qualify if:
- Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
You may not qualify if:
- History of myocardial infarction
- Current 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
- Recipient of any organ transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioDxlead
Study Sites (7)
Arizona Sun Family Medicine
Gilbert, Arizona, 85296, United States
Fiel Family Medicine
Tempe, Arizona, 85283, United States
Town Lake Internal Medicine
Woodstock, Georgia, 30189, United States
Maringouin Medical Center
Maringouin, Louisiana, 70757, United States
The Bonin Clinic
Zachary, Louisiana, 70791, United States
Triangle Primary Care
Wake Forest, North Carolina, 27587, United States
Comprehensive Physicians Associates
Youngstown, Ohio, 44505, United States
Related Publications (2)
Ladapo JA, Lyons H, Yau M, Rich P, Newton D, Bruce-Mensah K, Johnson A, Zhou Y, Stemkowski S, Monane M. Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test: results from a prospective registry study. Am J Med Qual. 2015 Jul-Aug;30(4):345-52. doi: 10.1177/1062860614532517. Epub 2014 May 5.
PMID: 24798176RESULTLadapo 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Zapien, MS
CardioDx
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2012
First Posted
March 20, 2012
Study Start
April 1, 2012
Primary Completion
March 1, 2013
Study Completion
May 1, 2013
Last Updated
January 31, 2019
Record last verified: 2019-01