Cardiovascular DiseasesMLQSENCT04193475
Machine Learning in Quantitative Stress Echocardiography
An observational study of Cardiovascular Diseases and Ischaemic Heart Disease, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Greater diagnostic accuracy is required to find out who is at risk of a heart attack as this can reduce the requirement of more invasive downstream tests and thereby improve the patient experience and also reduce their exposure to risk. Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Cardiovascular Diseases, Ischaemic Heart Disease
- What is being tested?
- Analysis
- How many people
- 1,250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2019to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: All patients will be recruited into this study as a single group, with an age range of 20 - 89 years and with no restriction according to their pre-test probabilities of coronary artery disease. They will be eligible for inclusion so long as they have chest pain or another clinical indication for stress testing.
Who may be able to join
- Clinically suitable for stress echocardiography examination
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Castle Hill Hospital
Cottingham, HU165JQ
Imran Sunderji, imran.sunderji@nhs.net
About this study
Greater diagnostic accuracy is required to find out who is at risk of a heart attack as this can reduce the requirement of more invasive downstream tests and thereby improve the patient experience and also reduce their exposure to risk. Stress echocardiography is a routine clinical test that involves using ultrasound to image the heart whilst it is under stress to assess the risk of a heart attack.
This study will focus on developing more accurate analysis tools to interpret the results of these stress echocardiographic scans. New methods will be tested to measure the function of each part of the heart muscle, using advanced analysis of the information obtained when high-frequency sound waves are bounced off the heart inside the chest. The researchers will measure and report exact heart function during stress, so that they will be able to recognise normal hearts and those with any disease. New computer methods will be developed to display any abnormality, which will make it easier for doctors to choose the best treatment for patients who are at risk.
The goals and potential benefits of this research proposal are to update the interpretation of a routinely used clinical test (stress echocardiography) to produce a reliable new method for diagnosing the precise effects of diseased arteries on the function of the heart muscle; to develop new computer graphics that adapt to show individual risks for each patient; and to implement new computer models that can be constantly updated
Read the detailed description
New onset chest pain is a common presenting complaint and can be a marker of significant cardiovascular disease and risk of myocardial infarction and death; therefore obtaining an accurate diagnosis is critical to guide patient management. It is noteworthy that only 40-50% of patients who have invasive arteriography subsequently undergo revascularisation. This underscores the imprecision of the initial tests employed prior to arteriography.
Historically electrocardiographic stress testing during exercise has been used to detect inducible myocardial ischaemia but its diagnostic sensitivity and specificity are low (about 65%). Diagnostic accuracy can be improved by by incorporating echocardiography or single photon emission computed tomography. Current NICE guidelines recommend that patients with chest pain of recent onset should be investigated with CT coronary angiography as a first line, and if this reveals a significant stenosis then a functional imaging test should be performed.
The Myocardial Doppler in Stress Echocardiography (MYDISE) study assessed the diagnostic value of quantitative stress echocardiography during the infusion of dobutamine, a short-acting synthetic catecholamine that acts on β-1 adrenergic receptors to increase heart rate and myocardial contractility. Measuring the systolic velocities of LV long-axis function at peak stress had good reproducibility (coefficients of variation in basal segments 9-14% at rest and 11-18% at peak stress) and similar sensitivities and specificities (about 70%) to published studies in which expert observers reported wall motion scores. When adjusted for the independent effects of age, gender and heart rate, however, diagnostic accuracy increased significantly with C statistics (area under receiver-operator curves) up to 90%.
Visual analysis of stress echocardiography to detect myocardial ischaemia depends on qualitative assessment of multiple parameters. Major studies of quantitative stress echocardiography have been limited to identifying the single best echocardiographic variable, and they have used diameter stenosis as the reference criterion. Progressive subclinical reductions of regional (long-axis) myocardial function have been demonstrated in subjects with cardiovascular risk factors, affecting myocardial deformation (strain and strain rate) as well as velocities. Ischaemia changes the timing of events during the cardiac cycle - for example prolonging pre-ejection and post-ejection phases. These factors confirm the clinical need for objective measurement of regional myocardial function throughout the cardiac cycle.
It is now possible to create algorithms that are based not just on a single time point (e.g., peak velocity) but instead rely on analysis of the whole of the velocity trace. This concept can also be extended to include strain and strain rate curves. Investigators at Universitat Pompeu Fabra, Barcelona, have developed this approach to create a statistical atlas of the heart to detect dyssynchrony. A similar concept has been applied using multiple kernel learning to patients with dyspnoea who have undergone exercise stress testing to identify those with evidence of diastolic heart failure.This has enabled velocity traces taken from the whole of the cardiac cycle to be compared and discriminated between control subjects (with and without dyspnoea) and those diagnosed with heart failure with preserved ejection fraction (HFpEF); the major differences observed are in early diastolic function. This application has not previously been used to explore inducible myocardial ischaemia in stress echocardiography, but similar findings might be expected, as changes during diastole are amongst the earliest and most sensitive indicators of myocardial ischaemia. Individuals at the University of Leuven (Prof Jan D'hooge) have recently developed supervised machine-learning methods that allow for automatic classification of myocardial segments based on their local mechanical behaviour (i.e. velocity/strain/strain rate) after going through a training phase; the proposed machine-learning approach outperforms expert wall motion readings as well as expert interpretation of segmental strain (rate) traces in classifying ischemic segments.
- Conditions
- Cardiovascular Diseases, Ischaemic Heart Disease
- Being tested
- Analysis
- Keywords
- Chest pain, Angina, Deformation imaging, Tissue doppler imaging, Strain, Velocity
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Chest Pain, Angina Pectoris, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnalysisOther
No intervention planned. Novel analysis of echocardiographic data.
| Study group | Role | What they receive |
|---|---|---|
| Chest pain | Individuals presenting with chest pain requiring a stress echocardiogram. Receives: Other: Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inducible myocardial ischaemia
Diagnostic performance of the machine learning classifier for the detection of inducible myocardial ischaemia as determined by reduced coronary flow reserve
Measured: 3 years
Secondary outcomes (4)
Workload
Diagnostic performance of workload (units = watts) for the detection of inducible myocardial ischaemia as determined by reduced coronary flow reserve.
Measured: 3 years
Velocity
Diagnostic performance of velocity (units = m/s) for the detection of myocardial functional reserve compared with quantitative coronary arteriography and with coronary flow reserve.
Measured: 3 years
Strain rate
Diagnostic performance of strain rate (units = s^-1) for the detection of myocardial functional reserve compared with quantitative coronary arteriography and with coronary flow reserve.
Measured: 3 years
Strain
Diagnostic performance of strain (units = s) for the detection of myocardial functional reserve compared with quantitative coronary arteriography and with coronary flow reserve.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start22 Nov 2019
- Primary completion1 Aug 2021
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Barts & The London NHS Trust, Cardiff and Vale University Health Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193475
- Sponsor's protocol ID
- R2458
- Acronym
- MLQSE
- Status last verified
- Mar 2025
- First submitted
- 18 Nov 2019
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning in Quantitative Stress Echocardiography
- ClinicalTrials.gov ID
- NCT04193475
- Acronym / sponsor ID
- MLQSE / R2458
- Conditions
- Cardiovascular Diseases, Ischaemic Heart Disease
- Keywords
- Chest pain, Angina, Deformation imaging, Tissue doppler imaging, Strain, Velocity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- Barts & The London NHS Trust, Cardiff and Vale University Health Board
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 10 Dec 2019 (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.
Greater diagnostic accuracy is required to find out who is at risk of a heart attack as this can reduce the requirement of more invasive downstream tests and thereby improve the patient experience and also reduce their exposure to risk. Stress echocardiography is a routine clinical test that involves using ultrasound to image the heart whilst it is under stress to assess the risk of a heart attack.
This study will focus on developing more accurate analysis tools to interpret the results of these stress echocardiographic scans. New methods will be tested to measure the function of each part of the heart muscle, using advanced analysis of the information obtained when high-frequency sound waves are bounced off the heart inside the chest. The researchers will measure and report exact heart function during stress, so that they will be able to recognise normal hearts and those with any disease. New computer methods will be developed to display any abnormality, which will make it easier for doctors to choose the best treatment for patients who are at risk.
The goals and potential benefits of this research proposal are to update the interpretation of a routinely used clinical test (stress echocardiography) to produce a reliable new method for diagnosing the precise effects of diseased arteries on the function of the heart muscle; to develop new computer graphics that adapt to show individual risks for each patient; and to implement new computer models that can be constantly updated
Detailed description
New onset chest pain is a common presenting complaint and can be a marker of significant cardiovascular disease and risk of myocardial infarction and death; therefore obtaining an accurate diagnosis is critical to guide patient management. It is noteworthy that only 40-50% of patients who have invasive arteriography subsequently undergo revascularisation. This underscores the imprecision of the initial tests employed prior to arteriography.
Historically electrocardiographic stress testing during exercise has been used to detect inducible myocardial ischaemia but its diagnostic sensitivity and specificity are low (about 65%). Diagnostic accuracy can be improved by by incorporating echocardiography or single photon emission computed tomography. Current NICE guidelines recommend that patients with chest pain of recent onset should be investigated with CT coronary angiography as a first line, and if this reveals a significant stenosis then a functional imaging test should be performed.
The Myocardial Doppler in Stress Echocardiography (MYDISE) study assessed the diagnostic value of quantitative stress echocardiography during the infusion of dobutamine, a short-acting synthetic catecholamine that acts on β-1 adrenergic receptors to increase heart rate and myocardial contractility. Measuring the systolic velocities of LV long-axis function at peak stress had good reproducibility (coefficients of variation in basal segments 9-14% at rest and 11-18% at peak stress) and similar sensitivities and specificities (about 70%) to published studies in which expert observers reported wall motion scores. When adjusted for the independent effects of age, gender and heart rate, however, diagnostic accuracy increased significantly with C statistics (area under receiver-operator curves) up to 90%.
Visual analysis of stress echocardiography to detect myocardial ischaemia depends on qualitative assessment of multiple parameters. Major studies of quantitative stress echocardiography have been limited to identifying the single best echocardiographic variable, and they have used diameter stenosis as the reference criterion. Progressive subclinical reductions of regional (long-axis) myocardial function have been demonstrated in subjects with cardiovascular risk factors, affecting myocardial deformation (strain and strain rate) as well as velocities. Ischaemia changes the timing of events during the cardiac cycle - for example prolonging pre-ejection and post-ejection phases. These factors confirm the clinical need for objective measurement of regional myocardial function throughout the cardiac cycle.
It is now possible to create algorithms that are based not just on a single time point (e.g., peak velocity) but instead rely on analysis of the whole of the velocity trace. This concept can also be extended to include strain and strain rate curves. Investigators at Universitat Pompeu Fabra, Barcelona, have developed this approach to create a statistical atlas of the heart to detect dyssynchrony. A similar concept has been applied using multiple kernel learning to patients with dyspnoea who have undergone exercise stress testing to identify those with evidence of diastolic heart failure.This has enabled velocity traces taken from the whole of the cardiac cycle to be compared and discriminated between control subjects (with and without dyspnoea) and those diagnosed with heart failure with preserved ejection fraction (HFpEF); the major differences observed are in early diastolic function. This application has not previously been used to explore inducible myocardial ischaemia in stress echocardiography, but similar findings might be expected, as changes during diastole are amongst the earliest and most sensitive indicators of myocardial ischaemia. Individuals at the University of Leuven (Prof Jan D'hooge) have recently developed supervised machine-learning methods that allow for automatic classification of myocardial segments based on their local mechanical behaviour (i.e. velocity/strain/strain rate) after going through a training phase; the proposed machine-learning approach outperforms expert wall motion readings as well as expert interpretation of segmental strain (rate) traces in classifying ischemic segments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest pain | – | Other: AnalysisIndividuals presenting with chest pain requiring a stress echocardiogram. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients will be recruited into this study as a single group, with an age range of 20 - 89 years and with no restriction according to their pre-test probabilities of coronary artery disease. They will be eligible for inclusion so long as they have chest pain or another clinical indication for stress testing.
Key inclusion criteria (1 listed)
- Clinically suitable for stress echocardiography examination
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AnalysisNo intervention planned. Novel analysis of echocardiographic data. | Other | Chest pain |
Primary outcome
Inducible myocardial ischaemia
Time frame: 3 years
Diagnostic performance of the machine learning classifier for the detection of inducible myocardial ischaemia as determined by reduced coronary flow reserve
4 secondary outcomes
Workload
Time frame: 3 years
Velocity
Time frame: 3 years
Strain rate
Time frame: 3 years
Strain
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Cardiovascular Diseases and Ischaemic Heart Disease, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Sunderji, MBBS (07540844481, imran.sunderji@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inducible myocardial ischaemia (time frame: 3 years). 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 17 Feb 2026.