Coronary Artery DiseaseIMAGE-CADNCT01668290
Assessment of Patients With Suspected Coronary Artery Disease (CAD): What is the Best Initial Imaging Strategy?
An observational study of Coronary Artery Disease, run by Harald Becher at 1 site in Canada.
Trial summary
Patients who present with chest pain are investigated with tests designed to confirm or exclude the presence of Coronary Artery Disease (CAD), as well as determine risk of poor outcome. It is not known which imaging test would be best when used first for investigating a patient presenting with exertional chest pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 173 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women without known CAD who present with symptoms suggestive of CAD and require diagnostic/prognostic workup.
Who may be able to join
- Adult Age ≥ 18 years
- Presenting with symptoms suggestive of CAD requiring diagnostic/prognostic workup
- Suitable for Contrast Stress Echocardiography, SPECT and CCTA
- Able and willing to provide consent
Who cannot join
- Patients with documented CAD (previous invasive angiography, previous STEMI, previous PCI or CABG)
- NSTEMI, ACS within 3 months
- Previous diagnostic imaging tests in the past 6 months
- Women who are pregnant as evidenced by positive pregnancy test
- Breast feeding females
- Significant valvular heart disease (i.e. severe aortic stenosis or regurgitation or severe mitral regurgitation)
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- Hemodynamic instability (blood pressure >210/110 ml/Hg or <90/60 mm/Hg)
- Unavailability for follow-up
- Renal insufficiency, eGFR < 30 ml/minute unless on dialysis
- Known allergy to x-ray or echo contrast agents
- Weight exceeding specifications of nuclear equipment (>250 Kg)
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Patients With Suspected CAD: What is the Best Initial Imaging Strategy? Cardiac Computed Tomographic Angiography,(CCTA) vs Stress Echocardiography (SE) vs SPECT
Patients who present with chest pain are investigated with tests designed to confirm or exclude the presence of Coronary Artery Disease (CAD), as well as determine risk of poor outcome. It is not known which imaging test would be best when used first for investigating a patient presenting with exertional chest pain. This trial is designed to compare outcomes of the use of coronary CT, stress echocardiography and nuclear perfusion (SPECT) in a pilot study. Patients with no history of coronary disease presenting with chest pain will be randomly assigned to one of the three test modalities as the initial imaging test. The three imaging strategies will be compared regarding the subsequent use of healthcare resources over a year.
Read the detailed description
This is a pilot study on imaging strategies for diagnosis of coronary artery disease. The pilot trial aims to answer the question "Which non-invasive test (single photon emission computed tomography (SPECT), stress echocardiography or coronary CT angiography (CCTA)) is the best first test in suspected coronary artery disease with respect to patient outcome and downstream health costs?" Patients are randomly assigned to one of the imaging modalities. All imaging and therapeutic procedures in this trial are clinically indicated. The only change from standard patient management is the selection of the initial imaging test. Instead of leaving the selection of the initial imaging test to the referring physician (whose decision is not evidence based), patients presenting with chest pain that fall into the inclusion/exclusion criteria of the study will be randomly assigned to one of the imaging modalities. Patients will also be followed at 1, 6 and 12 months after enrolment to determine outcomes. The three imaging strategies will be compared regarding subsequent use of healthcare resources over a year. In most large cardiac centres, different imaging modalities are performed by different specialists and therefore an operating grant from one imaging specialty rarely covers the costs of other imaging specialties in comparative studies. To ensure a fair comparison between modalities, all modalities have to be equal. Previous comparative trials have been criticized for being biased towards the technique being promoted by the principal investigator. This trial is unique in that the directors of nuclear cardiology, coronary computed tomography and echocardiography are all specialists in their field and are running state-of-the-art services and were all involved in the early planning of this trial and their involvement has ensured trial design meets clinical need. The results of this trial will give insight into planning of a larger multicentre, multi-national study.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Stress Echocardiography, Single Photon Emission Computed Tomography, Cardiac Computed Tomographic Angiography, outcomes
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stress Echocardiography | Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Stress Echocardiography. | |
| SPECT | Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Single Photon Emission Computed Tomography (SPECT) | |
| CCTA | Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Cardiac Computed Tomographic Angiography (CCTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
healthcare resource utilization
Measured: 12 month
Secondary outcomes (7)
referral rates to coronary angiography following three different initial imaging tests in this patient population.
Measured: 12 month
coronary lesions which warrant revascularization (including those where it was warranted but not technically possible).
Measured: 12 month
radiation exposure from the initial and subsequent imaging procedures
Measured: 12 month
total mortality
Measured: 12 month
freedom from angina
Measured: 12 month
non-fatal myocardial infarction
Measured: 12 month
hospital admissions for angina
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2017
- Study completionJan 2017
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harald Becher
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, University of Alberta
- Responsible party
- Sponsor-investigator, Harald Becher, University of Alberta
- Investigators
- Harald Becher, MD,PhD,FRCP, Principal investigator, University of Alberta, Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668290
- Sponsor's protocol ID
- CMI 1D
- Other IDs
- Pro00026591
- Acronym
- IMAGE-CAD
- Status last verified
- Mar 2017
- First submitted
- 13 Aug 2012
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patients With Suspected CAD: What is the Best Initial Imaging Strategy? Cardiac Computed Tomographic Angiography,(CCTA) vs Stress Echocardiography (SE) vs SPECT
- ClinicalTrials.gov ID
- NCT01668290
- Acronym / sponsor ID
- IMAGE-CAD / CMI 1D
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Stress Echocardiography, Single Photon Emission Computed Tomography, Cardiac Computed Tomographic Angiography, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Harald BecherUniversity, hospital or other
- Collaborators
- Alberta Health services, University of Alberta
- Study start
- Jul 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 20 Aug 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.
Patients who present with chest pain are investigated with tests designed to confirm or exclude the presence of Coronary Artery Disease (CAD), as well as determine risk of poor outcome. It is not known which imaging test would be best when used first for investigating a patient presenting with exertional chest pain. This trial is designed to compare outcomes of the use of coronary CT, stress echocardiography and nuclear perfusion (SPECT) in a pilot study. Patients with no history of coronary disease presenting with chest pain will be randomly assigned to one of the three test modalities as the initial imaging test. The three imaging strategies will be compared regarding the subsequent use of healthcare resources over a year.
Detailed description
This is a pilot study on imaging strategies for diagnosis of coronary artery disease. The pilot trial aims to answer the question "Which non-invasive test (single photon emission computed tomography (SPECT), stress echocardiography or coronary CT angiography (CCTA)) is the best first test in suspected coronary artery disease with respect to patient outcome and downstream health costs?" Patients are randomly assigned to one of the imaging modalities. All imaging and therapeutic procedures in this trial are clinically indicated. The only change from standard patient management is the selection of the initial imaging test. Instead of leaving the selection of the initial imaging test to the referring physician (whose decision is not evidence based), patients presenting with chest pain that fall into the inclusion/exclusion criteria of the study will be randomly assigned to one of the imaging modalities. Patients will also be followed at 1, 6 and 12 months after enrolment to determine outcomes. The three imaging strategies will be compared regarding subsequent use of healthcare resources over a year. In most large cardiac centres, different imaging modalities are performed by different specialists and therefore an operating grant from one imaging specialty rarely covers the costs of other imaging specialties in comparative studies. To ensure a fair comparison between modalities, all modalities have to be equal. Previous comparative trials have been criticized for being biased towards the technique being promoted by the principal investigator. This trial is unique in that the directors of nuclear cardiology, coronary computed tomography and echocardiography are all specialists in their field and are running state-of-the-art services and were all involved in the early planning of this trial and their involvement has ensured trial design meets clinical need. The results of this trial will give insight into planning of a larger multicentre, multi-national study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stress Echocardiography | – | –Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Stress Echocardiography. |
| SPECT | – | –Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Single Photon Emission Computed Tomography (SPECT) |
| CCTA | – | –Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Cardiac Computed Tomographic Angiography (CCTA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women without known CAD who present with symptoms suggestive of CAD and require diagnostic/prognostic workup.
Key inclusion criteria (4 listed)
- Adult Age ≥ 18 years
- Presenting with symptoms suggestive of CAD requiring diagnostic/prognostic workup
- Suitable for Contrast Stress Echocardiography, SPECT and CCTA
- Able and willing to provide consent
Key exclusion criteria (12 listed)
- Patients with documented CAD (previous invasive angiography, previous STEMI, previous PCI or CABG)
- NSTEMI, ACS within 3 months
- Previous diagnostic imaging tests in the past 6 months
- Women who are pregnant as evidenced by positive pregnancy test
- Breast feeding females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
healthcare resource utilization
Time frame: 12 month
7 secondary outcomes
referral rates to coronary angiography following three different initial imaging tests in this patient population.
Time frame: 12 month
coronary lesions which warrant revascularization (including those where it was warranted but not technically possible).
Time frame: 12 month
radiation exposure from the initial and subsequent imaging procedures
Time frame: 12 month
total mortality
Time frame: 12 month
freedom from angina
Time frame: 12 month
non-fatal myocardial infarction
Time frame: 12 month
hospital admissions for angina
Time frame: 12 month
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 16 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Harald Becher, MD,PhD,FRCP principal investigator
University of Alberta, Alberta Health Services
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, run by Harald Becher at 1 site in Canada.
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 4 inclusion and 12 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 16 Mar 2017. 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 Canada. 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?
healthcare resource utilization (time frame: 12 month). 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 16 Mar 2017.