Ischemia, MyocardialDEVISENCT03659526
Quantitative Stress Echocardiography to Diagnose Myocardial Ischaemia
An observational study of Ischemia, Myocardial, run by University Hospital of Wales at 4 sites in 3 countries.
Trial summary
Patients with chest pain on exertion need a reliable non-invasive test to identify if they have inducible myocardial ischaemia. This would reduce the use of diagnostic coronary arteriography, avoid its risks and costs, and guide clinical decisions. Read more about this study
- Who is it for?
- Ages 20 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemia, Myocardial
- What is being tested?
- Deformation imaging
- How many people
- 390 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Jan 2016to 31 Oct 2021
- 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 20 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Secondary care referrals
Who may be able to join
- Chest pain, chest pain equivalent
Who cannot join
- acute coronary syndrome with elevated troponin, severe heart valve disease, uncontrolled hypertension (resting SBP >200mmHg), cardiomyopathy, contraindication to dobutamine, pregnancy
Trial locations and contacts
4 sites in 3 countries.
Alan G Fraser contact
4 sites in 3 countries
United Kingdom2 sites, 2 recruiting
- Recruiting
University Hospital Wales
Cardiff
Alan G Fraser
Alan G Fraser
- Not yet recruiting
Castle Hill Hospital
Cottingham
Imran D Sunderji
Imran D Sunderji
Sweden1 site, 1 recruiting
- Not yet recruiting
Danderyd Hospital
Stockholm
Reidar Winter
About this study
Official title: Development, Validation and Implementation of a New Quantitative Stress Echocardiographic Test for Myocardial Ischaemia
Patients with chest pain on exertion need a reliable non-invasive test to identify if they have inducible myocardial ischaemia. This would reduce the use of diagnostic coronary arteriography, avoid its risks and costs, and guide clinical decisions. Conventional stress echocardiography has poor reproducibility because it relies on qualitative and subjective interpretation. Quantitative approaches based on precise and reliable measurements of myocardial velocity, strain, strain rate and global longitudinal strain have been shown to be able to accurately diagnose myocardial ischaemia. A more accurate test using myocardial velocity imaging was not implemented by ultrasound vendors although it provided an objective measurement of myocardial functional reserve on a continuous scale from normality to severe ischaemia.
The investigators propose an original approach to create a diagnostic software tool that can be used in routine clinical practice. The investigators will extract and compare quantitative data obtained through myocardial velocity imaging and speckle tracking in subjects who undergo dobutamine stress echocardiography.
The data will be analysed using advanced computational mathematics including multiple kernel learning and joint statistics applied to multivariate data across multiple dimensions (including velocity, strain and strain rate traces). This approach will be validated against quantitative coronary arteriography and fractional flow reserve. The results will be displayed as parametric images and placed into a reporting tool. The output will determine the presence and severity of myocardial ischaemia. These new tools will have the capacity for iterative learning so that the precision of the diagnostic conclusions can be continuously refined.
- Conditions
- Ischemia, Myocardial
- Being tested
- Deformation imaging
- Keywords
- Myocardial velocity imaging, Strain, Strain rate, Speckle tracking, Deformation, Quantitative, Echocardiography, Machine learning
- Medical subject headings
- Myocardial Ischemia, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deformation imagingDiagnostic test
Deformation parameters derived using myocardial velocity imaging or speckle tracking
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy volunteers or if they have had normal invasive or CT coronary arteriography or other functional imaging test Receives: Diagnostic Test: Deformation imaging | |
| Deformation imaging | Significant coronary disease (diameter stenosis >50%) has been diagnosed on arteriography or on CT angiography. Fractional flow reserve will be measured as the reference criterion. Receives: Diagnostic Test: Deformation imaging | |
| High p(CAD) | Intermediate-to-high probability of significant epicardial coronary disease (>50%). Receives: Diagnostic Test: Deformation imaging | |
| All comers | Probability of severe disease ranging from 15 to 85%. Receives: Diagnostic Test: Deformation imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of quantitative measures of dobutamine stress echocardiography
Echocardiographic measurements of segmental myocardial velocity, strain, strain rate and wall motion scoring referenced against measurements derived from coronary angiography.
Measured: 18 months
Secondary outcomes (2)
Lowest dose of dobutamine to provoke measurable marker of inducible myocardial ischaemia
Using modelling techniques applied predict lowest dose of dobutamine to maintain diagnostic accuracy
Measured: 18 months
Diagnostic accuracy of using machine learning to interpret multiparametric and multidimensional datasets to diagnose myocardial ischaemia
Use modelling to combine pre-test probabilities (based on risk factors such as age), physiological factors (e.g., heart rate) that are associated with longitudinal function and data derived throughout the cardiac cycle (i.e., based on analysis of velocity or strain curves and not just a single value like peak velocity or strain).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start21 Jan 2016
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia, MyocardialStudies 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
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Universitat Pompeu Fabra, Hull University Teaching Hospitals NHS Trust, Danderyd Hospital
- Responsible party
- Principal investigator, Professor Alan G Fraser, University Hospital of Wales
- Investigators
- Alan G Fraser, Principal investigator, University Hospital Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659526
- Sponsor's protocol ID
- IRAS Project ID 136434
- Acronym
- DEVISE
- Status last verified
- Sep 2018
- First submitted
- 17 Aug 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Validation and Implementation of a New Quantitative Stress Echocardiographic Test for Myocardial Ischaemia
- ClinicalTrials.gov ID
- NCT03659526
- Acronym / sponsor ID
- DEVISE / IRAS Project ID 136434
- Conditions
- Ischemia, Myocardial
- Keywords
- Myocardial velocity imaging, Strain, Strain rate, Speckle tracking, Deformation, Quantitative, Echocardiography, Machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University Hospital of WalesUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Universitat Pompeu Fabra, Hull University Teaching Hospitals NHS Trust, Danderyd Hospital
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 6 Sep 2018 (actual)
- 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 with chest pain on exertion need a reliable non-invasive test to identify if they have inducible myocardial ischaemia. This would reduce the use of diagnostic coronary arteriography, avoid its risks and costs, and guide clinical decisions. Conventional stress echocardiography has poor reproducibility because it relies on qualitative and subjective interpretation. Quantitative approaches based on precise and reliable measurements of myocardial velocity, strain, strain rate and global longitudinal strain have been shown to be able to accurately diagnose myocardial ischaemia. A more accurate test using myocardial velocity imaging was not implemented by ultrasound vendors although it provided an objective measurement of myocardial functional reserve on a continuous scale from normality to severe ischaemia.
The investigators propose an original approach to create a diagnostic software tool that can be used in routine clinical practice. The investigators will extract and compare quantitative data obtained through myocardial velocity imaging and speckle tracking in subjects who undergo dobutamine stress echocardiography.
The data will be analysed using advanced computational mathematics including multiple kernel learning and joint statistics applied to multivariate data across multiple dimensions (including velocity, strain and strain rate traces). This approach will be validated against quantitative coronary arteriography and fractional flow reserve. The results will be displayed as parametric images and placed into a reporting tool. The output will determine the presence and severity of myocardial ischaemia. These new tools will have the capacity for iterative learning so that the precision of the diagnostic conclusions can be continuously refined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Deformation imagingHealthy volunteers or if they have had normal invasive or CT coronary arteriography or other functional imaging test |
| Deformation imaging | – | Diagnostic Test: Deformation imagingSignificant coronary disease (diameter stenosis >50%) has been diagnosed on arteriography or on CT angiography. Fractional flow reserve will be measured as the reference criterion. |
| High p(CAD) | – | Diagnostic Test: Deformation imagingIntermediate-to-high probability of significant epicardial coronary disease (>50%). |
| All comers | – | Diagnostic Test: Deformation imagingProbability of severe disease ranging from 15 to 85%. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care referrals
Key inclusion criteria (1 listed)
- Chest pain, chest pain equivalent
Key exclusion criteria (1 listed)
- acute coronary syndrome with elevated troponin, severe heart valve disease, uncontrolled hypertension (resting SBP >200mmHg), cardiomyopathy, contraindication to dobutamine, pregnancy
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 |
|---|---|---|
| Deformation imagingDeformation parameters derived using myocardial velocity imaging or speckle tracking | Diagnostic test | All comers, Control, Deformation imaging, High p(CAD) |
Primary outcome
Diagnostic accuracy of quantitative measures of dobutamine stress echocardiography
Time frame: 18 months
Echocardiographic measurements of segmental myocardial velocity, strain, strain rate and wall motion scoring referenced against measurements derived from coronary angiography.
2 secondary outcomes
Lowest dose of dobutamine to provoke measurable marker of inducible myocardial ischaemia
Time frame: 18 months
Diagnostic accuracy of using machine learning to interpret multiparametric and multidimensional datasets to diagnose myocardial ischaemia
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Ischemia, Myocardial
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
Alan G Fraser contact
Alan G Fraser principal investigator
University Hospital Wales
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia, Myocardial, run by University Hospital of Wales at 4 sites in 3 countries.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Belgium, Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran D Sunderji (+441482 875875, imran.sunderji@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of quantitative measures of dobutamine stress echocardiography (time frame: 18 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 6 Sep 2018.