Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making

Coronary Artery Disease Clinical Trial

— UCU-CARD  

Official title:

Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223286
• Other study ID #: CDX_000016
• Secondary ID: UCU-CARD
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: February 21, 2018
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2018
• Source: CardioDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• CAD
• Cardiovascular Diseases
• CHD
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• CVD
• Heart Diseases
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Corus CAD
Age/Sex/Gene Expression Score

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Blue Ridge	Georgia
United States	John C. Lincoln Heart Institute	Phoenix	Arizona
United States	Heart Associates	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
CardioDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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