Coronary Artery DiseaseREGISTRY-INCT01557855
Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx at 7 sites in United States.
Trial summary
The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians… 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
- 342 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2012to May 2013
- 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 will be enrolled at multiple qualified participating study centers that have incorporated Corus CAD (ASGES) for the diagnosis of obstructive CAD into their routine practice.
Who may be able to join
- Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
Who cannot join
- History of myocardial infarction
- Current MI or acute coronary syndrome
- Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- Any previous coronary Revascularization
- Any individuals with:
- Diabetes
Show all 14Show fewer
- Suspected unstable angina
- Systemic infections
- Systemic inflammatory conditions
- Any individuals currently taking:
- Steroids
- Immunosuppressive agents
- Chemotherapeutic agents
- Recipient of any organ transplant
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Arizona Sun Family Medicine
Gilbert, Arizona, 85296
Maringouin Medical Center
Maringouin, Louisiana, 70757
Fiel Family Medicine
Tempe, Arizona, 85283
Triangle Primary Care
Wake Forest, North Carolina, 27587
Town Lake Internal Medicine
Woodstock, Georgia, 30189
Comprehensive Physicians Associates
Youngstown, Ohio, 44505
The Bonin Clinic
Zachary, Louisiana, 70791
About this study
Official title: Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.
The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.
Read the detailed description
This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.
Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:
- No further cardiac testing or treatment
- Medical therapy for angina or non-cardiac chest pain
- Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.
Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD
- Being tested
- Corus CAD (ASGES)
- Keywords
- Corus CAD, ASGES, Age/Sex/Gene Expression Score, Gene Expression, GES, CAD, CVD, CHD, Precision Medicine, Clinical Utility, Registry, Coronary Artery Disease, Coronary Heart Disease, Cardiovascular Disease, Angina Pectoris, Chest Pain, Registry I, Registry-I
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of referral vs. Corus CAD (ASGES) score as continuous variables
Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days.
Measured: 30 Days
Secondary outcomes (1)
Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores.
composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days.
Measured: 30 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Zapien, MS, Study director, CardioDx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557855
- Sponsor's protocol ID
- CDX_000013
- Other IDs
- REGISTRY-I
- Acronym
- REGISTRY-I
- Status last verified
- Jan 2019
- First submitted
- 16 Mar 2012
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ladapo JA, Lyons H, Yau M, Rich P, Newton D, Bruce-Mensah K, Johnson A, Zhou Y, Stemkowski S, Monane M. Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test: results from a prospective registry study. Am J Med Qual. 2015 Jul-Aug;30(4):345-52. doi: 10.1177/1062860614532517. Epub 2014 May 5.
PubMed 24798176Ladapo JA, Herman L, Weiner BH, Rhees B, Castle L, Monane M, McPherson JA. Use of a blood test incorporating age, sex, and gene expression influences medical decision-making in the evaluation of women presenting with symptoms suggestive of obstructive coronary artery disease: summary results from two ambulatory care studies in primary care. Menopause. 2015 Nov;22(11):1224-30. doi: 10.1097/GME.0000000000000443.
PubMed 25828395
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
- Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.
- ClinicalTrials.gov ID
- NCT01557855
- Acronym / sponsor ID
- REGISTRY-I / CDX_000013
- 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
- 342 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Mar 2012 (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 objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.
Detailed description
This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.
Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:
- No further cardiac testing or treatment
- Medical therapy for angina or non-cardiac chest pain
- Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.
Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled at multiple qualified participating study centers that have incorporated Corus CAD (ASGES) for the diagnosis of obstructive CAD into their routine practice.
Key inclusion criteria (2 listed)
- Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
Key exclusion criteria (14 listed)
- History of myocardial infarction
- Current MI or acute coronary syndrome
- Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- Any previous coronary Revascularization
- Any individuals with:
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 | – |
Primary outcome
Rate of referral vs. Corus CAD (ASGES) score as continuous variables
Time frame: 30 Days
Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days.
1 secondary outcome
Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores.
Time frame: 30 Day
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.
- Results publication: PubMed 24798176Ladapo JA, Lyons H, Yau M, Rich P, Newton D, Bruce-Mensah K, Johnson A, Zhou Y, Stemkowski S, Monane M. Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test: results from a prospective registry study. Am J Med Qual. 2015 Jul-Aug;30(4):345-52. doi: 10.1177/1062860614532517. Epub 2014 May 5.
- Derived from this study: PubMed 25828395Ladapo JA, Herman L, Weiner BH, Rhees B, Castle L, Monane M, McPherson JA. Use of a blood test incorporating age, sex, and gene expression influences medical decision-making in the evaluation of women presenting with symptoms suggestive of obstructive coronary artery disease: summary results from two ambulatory care studies in primary care. Menopause. 2015 Nov;22(11):1224-30. doi: 10.1097/GME.0000000000000443.
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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.
Michael Zapien, MS study director
CardioDx
7 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 7 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 14 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 7 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?
Rate of referral vs. Corus CAD (ASGES) score as continuous variables (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01557855, which also lists 2 linked publications.
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.