Coronary Artery DiseaseUCU-CARDNCT02223286
Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris, Chest Pain
- What is being tested?
- Corus CAD
- How many people
- 552 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2013to Aug 2014
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Symptoms suggestive of CAD, according to the opinion of the site clinician
- Age >= 21 years
Who cannot join
- History of myocardial infarction (MI)
- History of high risk unstable angina, systemic infections or systemic inflammatory conditions
- Current MI or acute coronary syndrome
- Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- Known/documented CAD
- History/current Diabetes Mellitus
- Taking steroids, immunosuppressive agents, or chemotherapeutic agents, at time of chest pain presentation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Piedmont Heart Institute
Blue Ridge, Georgia, 30513
John C. Lincoln Heart Institute
Phoenix, Arizona, 85037
Heart Associates
Youngstown, Ohio, 44504
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD
- Being tested
- Corus CAD
- 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
- 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 CADDiagnostic test
Age/Sex/Gene Expression Score
| Study group | Role | What they receive |
|---|---|---|
| ASGES (Treatment Group) | Patients who received a Corus CAD or Age/Sex/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD Receives: Diagnostic Test: Corus CAD | |
| Non-ASGES (Control Group) | Patients who underwent usual care testing and did not receive a Corus CAD or Age/SEX/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionAug 2014
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
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Hoffman, DO, Principal investigator, Northeast Ohio Medical UniversityLawrence Kline, DP, Principal investigator, John C. Lincoln Heart InstituteJaime Burkle, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223286
- Sponsor's protocol ID
- CDX_000016
- Other IDs
- UCU-CARD
- Acronym
- UCU-CARD
- Status last verified
- Feb 2018
- First submitted
- 19 Aug 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making
- ClinicalTrials.gov ID
- NCT02223286
- Acronym / sponsor ID
- UCU-CARD / CDX_000016
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD
- Keywords
- Corus CAD, ASGES, Age/Sex/Gene Expression Score, Gene Expression, GES, CAD, CVD, CHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Aug 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASGES (Treatment Group) | – | Diagnostic Test: Corus CADPatients who received a Corus CAD or Age/Sex/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD |
| Non-ASGES (Control Group) | – | –Patients who underwent usual care testing and did not receive a Corus CAD or Age/SEX/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Symptoms suggestive of CAD, according to the opinion of the site clinician
- Age >= 21 years
Key exclusion criteria (7 listed)
- History of myocardial infarction (MI)
- History of high risk unstable angina, systemic infections or systemic inflammatory conditions
- Current MI or acute coronary syndrome
- Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- Known/documented CAD
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 CADAge/Sex/Gene Expression Score | Diagnostic test | ASGES (Treatment Group) |
Primary outcome
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.
Time frame: up to 24 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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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.
David Hoffman, DO principal investigator
Northeast Ohio Medical University
Lawrence Kline, DP principal investigator
John C. Lincoln Heart Institute
Jaime Burkle, MD principal investigator
Piedmont Heart Institute
3 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 3 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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. (time frame: up to 24 months). 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 22 Feb 2018.