Coronary Artery DiseaseCU-PCPNCT02158754
Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx at 9 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris, Chest Pain
- What is being tested?
- Corus CAD (ASGES)
- How many people
- 0 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Bells Medical Clinic
Bells, Texas, 75414
J. Frank Martin, LLC
Columbia, South Carolina, 29229
Texas Familicare
Hurst, Texas, 76054
South Carolina Internal Medicine Associates LLC
Irmo, South Carolina, 29063
Internet Medical Group
Rutherford, New Jersey, 07070
Colonial Family Practice
Sumter, South Carolina, 29150
Triangle Primary Care
Wake Forest, North Carolina, 27587
Comprehensive Physicians Associates, LLC
Youngstown, Ohio, 44505
Northside Medical Center
Youngstown, Ohio, 44505
About this study
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).
Read the 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.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, CAD, CVD
- Being tested
- Corus CAD (ASGES)
- 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
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corus CAD (ASGES)Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Corus CAD (ASGES) | |
| Control | Matched subjects in the same practice that did NOT receive Corus CAD (ASGES) as part of their diagnostic workup. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 120 days
Secondary outcomes (1)
Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects
Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects, allowing for physician-dependent rates.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Study halted due to low investigator involvement; no patients enrolled in study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Monane, MD, FACP, Study chair, CardioDx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158754
- Sponsor's protocol ID
- CDX_000021
- Other IDs
- CU-PCP
- Acronym
- CU-PCP
- Status last verified
- Jan 2019
- First submitted
- 5 Jun 2014
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician Utilization of Corus CAD (or ASGES) in Primary Care Provider Decision Making
- ClinicalTrials.gov ID
- NCT02158754
- Acronym / sponsor ID
- CU-PCP / CDX_000021
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, CAD, CVD
- Keywords
- Corus CAD, ASGES, Coronary Artery Disease, Gene Expression, Age/Sex/Gene Expression Score, GES, Angina Pectoris, Chest Pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study halted due to low investigator involvement; no patients enrolled in study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corus CAD (ASGES) | – | Diagnostic Test: 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
- Symptoms suggestive of obstructive CAD, according to the opinion of the site clinician
- Eligible for Corus CAD (ASGES) (see exclusion criteria)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corus CAD (ASGES) | Diagnostic test | Corus CAD (ASGES) |
Primary outcome
Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group.
Time frame: 120 days
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).
1 secondary outcome
Tests/referrals ordered, between low score Corus CAD (ASGES) subjects and control subjects
Time frame: 120 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Monane, MD, FACP study chair
CardioDx
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in advanced cardiac testing in the low Corus CAD (Age/Sex/Gene Expression score - ASGES) score (<=15) group. (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.