Clinical trial NCT02223286: Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making
Official title: Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Diseases
Coronary Heart Disease
CAD
CVD
CHD
Keywords: Corus CAD
ASGES
Age/Sex/Gene Expression Score
Gene Expression
GES
CAD
CVD
CHD
Precision Medicine
Clinical Utility
Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Disease
Coronary Heart Disease
UCU-CARD
Lead sponsor: CardioDx
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 552
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: John C. Lincoln Heart Institute
state: Arizona
city: Blue Ridge
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Youngstown
country: United States
facility: Heart Associates
state: Ohio
Study officials:
affiliation: Northeast Ohio Medical University
name: David Hoffman, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: John C. Lincoln Heart Institute
name: Lawrence Kline, DP
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Heart Institute
name: Jaime Burkle, MD
role: PRINCIPAL_INVESTIGATOR
References: