Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making
| Status: | Completed |
|---|---|
| Conditions: | Angina, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 99 |
| Updated: | 2/24/2018 |
| Start Date: | March 2013 |
| End Date: | August 2014 |
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.
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.
The UCU-CARD (Understanding Clinician Utility-Cardiology) study is a retrospective,
matched-cohort evaluation of diagnostic testing in a community-based cardiology practice
setting that used a personalized age, sex, and gene expression test during early work-up of
patients with symptoms suggestive of obstructive CAD (http://www.clinicaltrials.gov,
NCT02223286). The study measured the rates of advanced cardiac diagnostic testing after
initial work-up, including stress testing with imaging, CTA, or ICA. Rates of advanced
diagnostic testing for patients who received the age, sex, and gene expression test (ASGES)
were compared with testing rates for matched historical controls (usual care). The study
hypothesis was that incorporating the age, sex, and gene expression testing early in the
diagnostic work-up pathway would permit the identification of patients for whom advanced
diagnostic testing was not required, thereby avoiding unnecessary testing and enabling
cardiologists to focus their diagnostic resources more efficiently.
This single-center study was conducted at the North Phoenix Heart Center (Phoenix, AZ), a
community-based group cardiology practice that receives patients on referral from primary
care physicians and other specialists in the surrounding area. The practice incorporated age,
sex, and gene expression testing into its diagnostic protocol beginning in June 2011. Data
collection was completed in December 2013. Institutional Review Board (IRB) approval of the
study protocol was granted by Quorum Review. Informed consent waivers were granted as data
collection was retrospective and all data were de-identified.
matched-cohort evaluation of diagnostic testing in a community-based cardiology practice
setting that used a personalized age, sex, and gene expression test during early work-up of
patients with symptoms suggestive of obstructive CAD (http://www.clinicaltrials.gov,
NCT02223286). The study measured the rates of advanced cardiac diagnostic testing after
initial work-up, including stress testing with imaging, CTA, or ICA. Rates of advanced
diagnostic testing for patients who received the age, sex, and gene expression test (ASGES)
were compared with testing rates for matched historical controls (usual care). The study
hypothesis was that incorporating the age, sex, and gene expression testing early in the
diagnostic work-up pathway would permit the identification of patients for whom advanced
diagnostic testing was not required, thereby avoiding unnecessary testing and enabling
cardiologists to focus their diagnostic resources more efficiently.
This single-center study was conducted at the North Phoenix Heart Center (Phoenix, AZ), a
community-based group cardiology practice that receives patients on referral from primary
care physicians and other specialists in the surrounding area. The practice incorporated age,
sex, and gene expression testing into its diagnostic protocol beginning in June 2011. Data
collection was completed in December 2013. Institutional Review Board (IRB) approval of the
study protocol was granted by Quorum Review. Informed consent waivers were granted as data
collection was retrospective and all data were de-identified.
Inclusion Criteria:
1. Symptoms suggestive of CAD, according to the opinion of the site clinician
2. Age >= 21 years
Exclusion Criteria:
1. History of myocardial infarction (MI)
2. History of high risk unstable angina, systemic infections or systemic inflammatory
conditions
3. Current MI or acute coronary syndrome
4. Current New York Heart Association (NYHA) class III or IV congestive heart failure
symptoms
5. Known/documented CAD
6. History/current Diabetes Mellitus
7. Taking steroids, immunosuppressive agents, or chemotherapeutic agents, at time of
chest pain presentation
We found this trial at
3
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