Angina PectorisIMPACT-CARDNCT01251302
Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern
An observational study of Angina Pectoris and Coronary Artery Disease, run by CardioDx at 1 site in United States.
Trial summary
To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for 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
- Angina Pectoris, Coronary Artery Disease, Chest Pain
- What is being tested?
- Corus CAD (ASGES)
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2012
- 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 study will enroll a patient population that present with chest pain or anginal equivalent symptoms who are referred to a cardiologist for evaluation.
Who may be able to join
- Stable chest pain, typical or atypical angina or anginal equivalent
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.
Who cannot join
- History of myocardial infarction
- Current myocardial infarct (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
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern
To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.
Read the detailed description
A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.
- Conditions
- Angina Pectoris, Coronary Artery Disease, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD
- Being tested
- Corus CAD (ASGES)
- Keywords
- Corus CAD, Age/Sex/Gene Expression Score, Molecular Genetics, Atherosclerosis, ASGES, Gene Expression, GES, CAD, CVD, CHD, Clinical Utility, Precision Medicine, Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Disease, Coronary Heart Disease, IMPACT, IMPACT-CARD
- Medical subject headings
- Angina Pectoris, Coronary Artery Disease, Chest Pain, Cardiovascular Diseases, Coronary Disease, Atherosclerosis, Tooth, Impacted
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 |
|---|---|---|
| Prospective Cohort | Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis. Receives: Diagnostic Test: Corus CAD (ASGES) | |
| Retrospective Cohort | Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) to assist in diagnosis. Note: this cohort was historical. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision
Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:
- No further cardiac testing or treatment
- Medical therapy for angina or non-cardiac chest pain
- Stress testing with or without imaging
- CT angiography
- Invasive cardiac catheterization
Measured: Up to 7 days
Change in management practice pattern between after Corus CAD decision and historical cohort.
Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:
- No further cardiac testing or treatment
- Medical therapy for angina or non-cardiac chest pain
- Stress testing with or without imaging
- CT angiography
- Invasive cardiac catheterization
Measured: up to 195 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies 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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Zapien, MS, Study director, CardioDx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251302
- Sponsor's protocol ID
- CDX_000011
- Other IDs
- IMPACT-CARD
- Acronym
- IMPACT-CARD
- Status last verified
- Jan 2019
- First submitted
- 30 Nov 2010
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
McPherson JA, Davis K, Yau M, Beineke P, Rosenberg S, Monane M, Fredi JL. The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery disease: results from the IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial. Crit Pathw Cardiol. 2013 Jun;12(2):37-42. doi: 10.1097/HPC.0b013e3182822bd0.
PubMed 23680805
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
- Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern
- ClinicalTrials.gov ID
- NCT01251302
- Acronym / sponsor ID
- IMPACT-CARD / CDX_000011
- Conditions
- Angina Pectoris, Coronary Artery Disease, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD
- Keywords
- Corus CAD, Age/Sex/Gene Expression Score, Molecular Genetics, Atherosclerosis, ASGES, Gene Expression, GES, CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Dec 2010 (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.
To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.
Detailed description
A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Diagnostic Test: Corus CAD (ASGES)Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis. |
| Retrospective Cohort | – | –Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) to assist in diagnosis. Note: this cohort was historical. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll a patient population that present with chest pain or anginal equivalent symptoms who are referred to a cardiologist for evaluation.
Key inclusion criteria (2 listed)
- Stable chest pain, typical or atypical angina or anginal equivalent
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.
Key exclusion criteria (14 listed)
- History of myocardial infarction
- Current myocardial infarct (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 | Prospective Cohort |
Primary outcome
Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision
Time frame: Up to 7 days
Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: 1. No further cardiac testing or treatment 2. Medical therapy for angina or non-cardiac chest pain 3. Stress testing with or without imaging 4. CT angiography 5. Invasive cardiac catheterization
Change in management practice pattern between after Corus CAD decision and historical cohort.
Time frame: up to 195 days
Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: 1. No further cardiac testing or treatment 2. Medical therapy for angina or non-cardiac chest pain 3. Stress testing with or without imaging 4. CT angiography 5. Invasive cardiac catheterization
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 23680805McPherson JA, Davis K, Yau M, Beineke P, Rosenberg S, Monane M, Fredi JL. The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery disease: results from the IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial. Crit Pathw Cardiol. 2013 Jun;12(2):37-42. doi: 10.1097/HPC.0b013e3182822bd0.
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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, 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 Angina Pectoris and Coronary Artery Disease, 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 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 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?
Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision (time frame: Up to 7 days). The study lists 2 primary outcomes in all. 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 NCT01251302, which also lists 1 linked publication.
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.