Trials / Completed
CompletedNCT02223286
Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 552 (actual)
- Sponsor
- CardioDx · Industry
- Sex
- All
- Age
- 21 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
- Coronary Artery Disease
- Angina Pectoris
- Chest Pain
- Cardiovascular Diseases
- Coronary Heart Disease
- CAD
- CVD
- CHD
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Corus CAD | Age/Sex/Gene Expression Score |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2014-06-01
- Completion
- 2014-08-01
- First posted
- 2014-08-22
- Last updated
- 2018-02-22
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02223286. Inclusion in this directory is not an endorsement.