Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making
UCU-CARD
2 other identifiers
observational
552
1 country
3
Brief Summary
The purpose of this study is to understand the use of Corus CAD also known as Age/Sex/Gene Expression score (ASGES) in the clinical decision making process of patients who underwent the evaluation of chest pain or anginal equivalent symptoms. Specifically, to better understand whether the use of the assay in clinical decision making resulted in changes in noninvasive diagnostic test ordering or diagnostic yield of additional tests ordered and/or invasive angiography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
3 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
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
August 22, 2014
CompletedFebruary 22, 2018
February 1, 2018
1.3 years
August 19, 2014
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary measure of this study is the number of advanced diagnostic tests in ASGES (treatment group) patients compared to the number of advanced diagnostic tests in non-ASGES (control group) patients.
The primary study endpoint was the percentage of patients for whom advanced diagnostic testing was ordered-stress testing with imaging, computed tomography angiography, or invasive coronary angiography.
up to 24 months
Study Arms (2)
ASGES (Treatment Group)
Patients who received a Corus CAD or Age/Sex/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD
Non-ASGES (Control Group)
Patients who underwent usual care testing and did not receive a Corus CAD or Age/SEX/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD
Interventions
Eligibility Criteria
The patient population of interest and the main inclusion criterion for inclusion is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction, and the utilization of Corus CAD (Age/Sex/Gene Expression score - ASGES). Additionally, subjects with similar chest pain (or angina equivalent) whom did not undergo Corus CAD (ASGES) will be included as a control group, to understand the diagnostic evaluation and management of patients prior to Corus CAD (ASGES) use.
You may qualify if:
- Symptoms suggestive of CAD, according to the opinion of the site clinician
- Age \>= 21 years
You may not qualify if:
- History of myocardial infarction (MI)
- History of high risk unstable angina, systemic infections or systemic inflammatory conditions
- Current MI or acute coronary syndrome
- Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- Known/documented CAD
- History/current Diabetes Mellitus
- Taking steroids, immunosuppressive agents, or chemotherapeutic agents, at time of chest pain presentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioDxlead
Study Sites (3)
John C. Lincoln Heart Institute
Phoenix, Arizona, 85037, United States
Piedmont Heart Institute
Blue Ridge, Georgia, 30513, United States
Heart Associates
Youngstown, Ohio, 44504, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Hoffman, DO
Northeast Ohio Medical University
- PRINCIPAL INVESTIGATOR
Lawrence Kline, DP
John C. Lincoln Heart Institute
- PRINCIPAL INVESTIGATOR
Jaime Burkle, MD
Piedmont Heart Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2014
First Posted
August 22, 2014
Study Start
March 1, 2013
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
February 22, 2018
Record last verified: 2018-02