Clinical trial NCT02158754: Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making
Official title: Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Diseases
CAD
CVD
Coronary Heart Disease
CHD
Keywords: Corus CAD
ASGES
Coronary Artery Disease
Gene Expression
Age/Sex/Gene Expression Score
GES
Angina Pectoris
Chest Pain
Cardiovascular Disease
CAD
CVD
CHD
Coronary Heart Disease
Precision Medicine
Clinical Utility
Lead sponsor: CardioDx
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a retrospective chart review, in which only de-identified clinical data will be collected and analyzed. The main criterion for inclusion is the occurrence of chest pain (or anginal equivalent) in a subject without known significant CAD or a history of prior myocardial infarction, and the utilization of Corus CAD (Age/Sex/Gene Expression score - ASGES) for the Corus CAD Arm. Additionally, Corus CAD (ASGES) eligible subjects with similar chest pain (or angina equivalent) who did not undergo Corus CAD (ASGES) testing will be included as a control group.

Brief summary: This retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a Corus CAD (Age/Sex/Gene Expression score - ASGES) result compared to patients who did not have the test performed (matched control patients).

Detailed description: This retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a Corus CAD (Age/Sex/Gene Expression score - ASGES) result compared to patients who did not have the test performed (matched control patients). The data collected will be from primary care practices and will also assess one to two year health outcomes (MACE, procedure complications). Furthermore, in these real world practice settings, the study will investigate the economic impact of Corus CAD (ASGES) usage at each practice using practice specific data, when available.

Eligibility criteria: Inclusion Criteria:

For Corus CAD (Age/Sex/Gene Expression score - ASGES) arm:

* Symptoms suggestive of obstructive CAD, according to the opinion of the site clinician
* Age \>= 21 years
* Resulted Corus CAD (ASGES) test used during the evaluation and/or diagnosis of symptoms suggestive of obstructive coronary artery disease (CAD), preferably 1 year prior to data collection date.

For Control arm:

* Symptoms suggestive of obstructive CAD, according to the opinion of the site clinician
* Eligible for Corus CAD (ASGES) (see exclusion criteria)
* Matched to Corus CAD (ASGES) patients by sex, age +/-2.5 years, and presenting symptoms

Exclusion Criteria:

* History of myocardial infarction (MI) or CAD prior to the index evaluation
* Presentation of high risk unstable angina for the index evaluation
* Concurrent systemic infection or inflammatory process
* Concurrent MI or acute coronary syndrome
* Known diabetes mellitus diagnosis or laboratory test results suggestive of a diagnosis of diabetes mellitus (e.g., HbA1C \>=6.5)
* Use of steroids, immunosuppressive agents, or chemotherapeutic agents, at time of chest pain presentation

Primary outcomes:
measure: Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group.
timeFrame: 120 days
Secondary outcomes:
measure: Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects
timeFrame: 120 days
Other outcomes:
measure: Health outcomes ( MACE, procedure complications) between Corus CAD (ASGES) subjects and control subjects, between low score Corus CAD subjects and matched control subjects, and between low score Corus CAD subjects and non-low score Corus CAD subjects
timeFrame: up to 2 years
Locations:
city: Rutherford
country: United States
facility: Internet Medical Group
state: New Jersey
city: Wake Forest
country: United States
facility: Triangle Primary Care
state: North Carolina
city: Youngstown
country: United States
facility: Comprehensive Physicians Associates, LLC
state: Ohio
city: Youngstown
country: United States
facility: Northside Medical Center
state: Ohio
city: Columbia
country: United States
facility: J. Frank Martin, LLC
state: South Carolina
city: Irmo
country: United States
facility: South Carolina Internal Medicine Associates LLC
state: South Carolina
city: Sumter
country: United States
facility: Colonial Family Practice
state: South Carolina
city: Bells
country: United States
facility: Bells Medical Clinic
state: Texas
city: Hurst
country: United States
facility: Texas Familicare
state: Texas
Study officials:
affiliation: CardioDx
name: Mark Monane, MD, FACP
role: STUDY_CHAIR
References: