Study Stopped
Study halted due to low investigator involvement; no patients enrolled in study.
Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making
CU-PCP
2 other identifiers
observational
N/A
1 country
9
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2014
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJanuary 31, 2019
January 1, 2019
1 year
June 5, 2014
January 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group.
The primary endpoint of the study is the change in number of advanced cardiac diagnostic tests (exercise ECG, stress myocardial perfusion imaging (MPI), cardiac computed tomography angiography (CCTA) or invasive coronary angiography (ICA)) ordered and number of subject referrals to specialty care by the primary clinician, comparing low score Corus CAD (\<=15) patients (Corus CAD arm) and matched control patients who did not receive Corus CAD testing (control arm).
120 days
Secondary Outcomes (1)
Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects
120 days
Other Outcomes (1)
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
up to 2 years
Study Arms (2)
Corus CAD (ASGES)
Subjects receiving CorusCAD (ASGES) gene expression test as part of their diagnostic workup for typical and/or atypical symptoms of obstructive coronary artery disease.
Control
Matched subjects in the same practice that did NOT receive Corus CAD (ASGES) as part of their diagnostic workup.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Matched to Corus CAD (ASGES) patients by sex, age +/-2.5 years, and presenting symptoms
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioDxlead
Study Sites (9)
Internet Medical Group
Rutherford, New Jersey, 07070, United States
Triangle Primary Care
Wake Forest, North Carolina, 27587, United States
Comprehensive Physicians Associates, LLC
Youngstown, Ohio, 44505, United States
Northside Medical Center
Youngstown, Ohio, 44505, United States
J. Frank Martin, LLC
Columbia, South Carolina, 29229, United States
South Carolina Internal Medicine Associates LLC
Irmo, South Carolina, 29063, United States
Colonial Family Practice
Sumter, South Carolina, 29150, United States
Bells Medical Clinic
Bells, Texas, 75414, United States
Texas Familicare
Hurst, Texas, 76054, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mark Monane, MD, FACP
CardioDx
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 9, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
January 31, 2019
Record last verified: 2019-01