Coronary Artery DiseaseAACUNCT02405754
Clinical Utility of an Age, Sex, and Gene Expression Score (ASGES or Corus CAD) in African American Patients.
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx at 1 site in United States.
Trial summary
This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Age/Sex/Gene Expression score (ASGES) also knows as Corus CAD testing, by order of the Principal Investigator. 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
- 667 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects, who received Age/Sex/Gene Expression Score (ASGES) or Corus CAD testing, will be considered for enrollment by conducting a retrospective review of medical charts. Subjects who satisfy the following inclusion and exclusion criteria will be included for data abstraction.
Who may be able to join
- All patients receiving Corus CAD (ASGES) from 2008-2012.
Who cannot join
- If any of the following co-moribidities, medical conditions, or current medical statuses are noted in the patient medical chart, s/he will be excluded from the analysis dataset:
- History of diabetes;
- Revascularization or myocardial infarction;
- Systemic infection or inflammatory condition; or
- Use of steroids, immunosuppressive agents, or chemotherapeutic agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Medical Group - Dayton Primary
Dayton, Ohio, 45402
About this study
Official title: Clinical Utility of an Age, Sex and Gene Expression Score (ASGES or Corus CAD) in the Diagnostic Management of Obstructive Coronary Artery Disease in African American Patients in a Primary Care Setting
This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Age/Sex/Gene Expression score (ASGES) also knows as Corus CAD testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously.
Read the detailed description
Though the diagnostic properties of Age/Sex/Gene Expression Score (ASGES) or Corus CAD have been evaluated in previous observational studies, there are limited data regarding how primary care clinicians are using the results of the test in the care and management of patients with symptoms suggestive of angina in the African-America patient population. This retrospective study is designed to examine the relationship between the Corus CAD (ASGES) score and patterns of care regarding cardiology referral or further cardiac diagnostic testing in an African-American patient population single-center site.
This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Corus CAD (ASGES) testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously. IRB approval will be requested with a waiver of informed consent, as no identifying information will be collected.
This retrospective study is designed to understand the patterns of care, including referrals for cardiac care and testing (including referrals to a cardiologist, exercise stress testing, cardiac computerized tomography angiography (CCTA), invasive cardiac angiography (ICA)) within an African-American patient population.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CHD
- Being tested
- Corus CAD (ASGES)
- Keywords
- Corus CAD, Personalized Medicine, CAD, ASGES, Age/Sex/Gene Expression Score, GES, CVD, CHD, Precision Medicine, Clinical Utility, Gene Expression, Coronary Heart Disease, Cardiovascular Disease, Chest Pain, Coronary Artery Disease, Angina Pectoris, exercise stress testing, CT angiography, invasive cardiac angiography, African-American patient
- 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
Age/Sex/Gene Expression Score - ASGES
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD test Receives: Diagnostic Test: Corus CAD (ASGES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD
Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD , expected follow-up up to 1 year
Measured: Expected follow-up up to 1 year after receiving Corus CAD testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completionApr 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 only
- Time perspective
- Retrospective
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Ross, MPH, Study director, CardioDx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405754
- Sponsor's protocol ID
- CDX_000024
- Other IDs
- AACU
- Acronym
- AACU
- Status last verified
- Jan 2019
- First submitted
- 23 Mar 2015
- 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
- Clinical Utility of an Age, Sex and Gene Expression Score (ASGES or Corus CAD) in the Diagnostic Management of Obstructive Coronary Artery Disease in African American Patients in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT02405754
- Acronym / sponsor ID
- AACU / CDX_000024
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CHD
- Keywords
- Corus CAD, Personalized Medicine, CAD, ASGES, Age/Sex/Gene Expression Score, GES, CVD, CHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Apr 2015 (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 is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Age/Sex/Gene Expression score (ASGES) also knows as Corus CAD testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously.
Detailed description
Though the diagnostic properties of Age/Sex/Gene Expression Score (ASGES) or Corus CAD have been evaluated in previous observational studies, there are limited data regarding how primary care clinicians are using the results of the test in the care and management of patients with symptoms suggestive of angina in the African-America patient population. This retrospective study is designed to examine the relationship between the Corus CAD (ASGES) score and patterns of care regarding cardiology referral or further cardiac diagnostic testing in an African-American patient population single-center site.
This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Corus CAD (ASGES) testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously. IRB approval will be requested with a waiver of informed consent, as no identifying information will be collected.
This retrospective study is designed to understand the patterns of care, including referrals for cardiac care and testing (including referrals to a cardiologist, exercise stress testing, cardiac computerized tomography angiography (CCTA), invasive cardiac angiography (ICA)) within an African-American patient population.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Diagnostic Test: Corus CAD (ASGES)Patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD test |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects, who received Age/Sex/Gene Expression Score (ASGES) or Corus CAD testing, will be considered for enrollment by conducting a retrospective review of medical charts. Subjects who satisfy the following inclusion and exclusion criteria will be included for data abstraction.
Key inclusion criteria (1 listed)
- All patients receiving Corus CAD (ASGES) from 2008-2012.
Key exclusion criteria (5 listed)
- If any of the following co-moribidities, medical conditions, or current medical statuses are noted in the patient medical chart, s/he will be excluded from the analysis dataset:
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)Age/Sex/Gene Expression Score - ASGES | Diagnostic test | Treatment Group |
Primary outcome
Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD
Time frame: Expected follow-up up to 1 year after receiving Corus CAD testing
Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD , expected follow-up up to 1 year
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 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.
Linda Ross, MPH study director
CardioDx, Inc.
1 site 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 1 site 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 1 inclusion and 5 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 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 1 site 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?
Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD (time frame: Expected follow-up up to 1 year after receiving Corus CAD testing). 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.