Coronary Artery DiseaseFINESSENCT07432620
Artificial Intelligence Stress Echo (FINESSE) Project
An observational study of Coronary Artery Disease and Chest Pain, run by Milton Keynes University Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to learn whether combining stress echocardiography (stress echo) results with routine clinical information can better predict important heart outcomes in adults (18+) with chest pain who were assessed for suspected coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Chest Pain, Myocardial Ischemia
- What is being tested?
- Dobutamine Stress Echocardiography
- How many people
- 2,281 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jun 2019to Oct 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single-centre retrospective cohort drawn from Milton Keynes University Hospital records, consisting of approximately 3,000 adults who underwent clinically indicated pharmacological (dobutamine) stress echocardiography for assessment of chest pain / suspected coronary artery disease (dataset dating back to 2002, covering ~15 years of reports). Stress echocardiography report variables are extracted and linked to routine clinical outcome data for analysis.
Who may be able to join
- Age 18 years or older at the time of the index stress echocardiography.
- Referred for pharmacological (dobutamine) stress echocardiography at Milton Keynes University Hospital for assessment of suspected coronary artery disease / chest pain.
- Stress echocardiography report available in the hospital dataset for data extraction and conversion into a structured database.
Who cannot join
- Age under 18 years at the time of the index stress echocardiography.
- No available/usable stress echocardiography report for extraction into the study database.
- Unable to link the record to follow-up outcome information using routine hospital systems (with attempted supplementary checks where needed).
- Patients who have registered a National Data Opt-out and are therefore not eligible for use of their confidential patient information for research/secondary purposes in this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Milton Keynes University Hospital
Milton Keynes, Buckinghamshire, MK6 5LD
About this study
Official title: Risk Prediction Model in Patients With Suspected Coronary Artery Disease Based on Contemporary Stress Echocardiography Data Using Artificial Intelligence
The goal of this observational study is to learn whether combining stress echocardiography (stress echo) results with routine clinical information can better predict important heart outcomes in adults (18+) with chest pain who were assessed for suspected coronary artery disease.
The main questions it aims to answer are:
Read more
Can an artificial intelligence / machine learning model using stress echo findings plus clinical factors (such as blood pressure, diabetes, smoking, other health conditions, medications, and body measurements) predict major heart-related events (such as heart attack, stroke, death related to heart disease, or the need for coronary procedures) more accurately than stress echo results alone?
Can the model help identify which patients are most likely to benefit from further invasive assessment and possible coronary revascularisation (for example, a stent or bypass surgery)?
Which combination of stress echo measurements and clinical factors contributes most to risk prediction?
Participants will:
Not be asked to attend extra visits or have additional tests for this study.
Have their existing stress echo reports and routinely collected hospital record data analysed (approximately 3,000 people who previously had dobutamine stress echo at Milton Keynes University Hospital).
In some cases, if outcomes are not fully available from hospital records, the research team may check additional sources (such as GP records, or contacting the patient if appropriate) to confirm whether a major heart-related event occurred.
Read the detailed description
This is a single-centre, retrospective observational study using an existing dataset of pharmacological (dobutamine) stress echocardiography (SE) reports generated within Milton Keynes University Hospital over approximately 15 years, starting from 2002. The SE dataset comprises reports/letters produced by a single, experienced clinician, which reduces inter-observer variability and supports consistent interpretation across the cohort.
Data sources and cohort construction
SE reports (in document format) will be converted into a structured research database. A computer science team will develop a generalisable approach to extract structured variables from the clinical SE reports, building on prior proof-of-concept work demonstrating feasibility of converting these reports into a database.
The dataset includes clinical variables (e.g., cardiovascular risk factors, comorbidities, prescribed medications, and anthropometrics) alongside SE-derived measures (including ischaemia detection and wall motion scoring at rest and peak stress).
Stress echocardiography technique (context for imaging-derived variables)
The study dataset reflects contemporary dobutamine SE practice at MKUH, with contrast-enhanced imaging used in the majority of cases (SonoVue contrast with rota pump infusion equipment). Studies were performed predominantly on Philips echocardiography systems, with image acquisition across standard stages (resting, intermediate, peak stress, and recovery) and standard views (apical 4-, 2-, and 3-chamber; parasternal long- and short-axis). Reporting used dedicated platforms enabling stage-by-stage comparison.
Outcome ascertainment and linkage
Following database completion, a research nurse will query the hospital Electronic Data Management system to ascertain major adverse cardiovascular events (MACE) for the cohort. Where outcomes cannot be confirmed from hospital systems (e.g., patients no longer served by the hospital), missing outcome information will be explored via primary care physician contact and/or patient contact as appropriate.
Data processing, quality checks, and handling missingness
Extracted data will undergo cleaning prior to analysis. Natural Language Processing (NLP) and feature engineering approaches will be used to transform extracted information into model-ready features. As part of preprocessing, data fields will be checked for completeness and consistency before modelling. Missing outcome data will be addressed through the external outcome checks described above.
Statistical / machine learning approach and internal validation
After preprocessing, subset feature selection methods will be applied to identify the most informative predictors for risk classification. Supervised learning will be used to discriminate between lower-risk cases and cases requiring further investigation, with additional modelling approaches (including regression techniques) planned to support quantification of disease stage in abnormal cases. Overfitting will be mitigated through use of techniques robust to overfitting (e.g., ensemble methods) and internal validation using k-fold cross-validation (five folds), ensuring separation of training and validation data.
Sample size and additional analyses
The study will utilise the available full dataset (approximately 3,000 patients) to maximise model development and internal validation. A cost analysis is also planned using the available data.
- Conditions
- Coronary Artery Disease, Chest Pain, Myocardial Ischemia, Angina Pectoris, Myocardial Infarction (MI)
- Being tested
- Dobutamine Stress Echocardiography
- Keywords
- Dobutamine stress echocardiography, Stress echocardiography, Coronary artery disease, Myocardial ischemia, Chest pain, Risk stratification, Machine learning, Artificial intelligence, Cardiovascular risk prediction, Major adverse cardiovascular events, Stroke
- Medical subject headings
- Coronary Artery Disease, Chest Pain, Myocardial Ischemia, Angina Pectoris, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dobutamine Stress EchocardiographyDiagnostic test
Clinically indicated dobutamine stress echocardiography performed as part of routine care for assessment of suspected coronary artery disease/chest pain. Echocardiographic images acquired at rest and during incremental dobutamine stress (with recovery imaging) are interpreted for inducible ischaemia and regional wall motion abnormalities (including wall motion scoring). Contrast enhancement may be used where needed to optimise endocardial border definition. For this observational study, no additional tests or procedures are performed beyond standard clinical practice; existing stress echocardiography reports and associated routine clinical data are analysed retrospectively.
| Study group | Role | What they receive |
|---|---|---|
| Dobutamine Stress Echocardiography Cohort | Adults who previously underwent clinically indicated dobutamine stress echocardiography at Milton Keynes University Hospital for assessment of chest pain/suspected coronary artery disease. Stress echocardiography findings and routinely collected clinical information from existing records will be extracted and linked to subsequent cardiovascular outcomes captured through routine care data. Analyses will examine differences in outcomes between participants with normal versus abnormal stress echocardiography findings (and across predicted risk strata generated by the model). Receives: Diagnostic Test: Dobutamine Stress Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE) - composite
Composite of fatal myocardial infarction, non-fatal myocardial infarction, stroke, planned coronary revascularisation, and unplanned coronary revascularisation. (yes/no)
Measured: From the index dobutamine stress echocardiography date until the first major adverse cardiovascular event or death (whichever occurs first), or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
Secondary outcomes (5)
fatal myocardial infarction
Fatal MI (yes/no)
Measured: From the index dobutamine stress echocardiography date until fatal myocardial infarction (MI as cause of death), or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
non-fatal myocardial infarction
non-fatal MI (yes/no)
Measured: From the index dobutamine stress echocardiography date until first non-fatal myocardial infarction, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
stroke
stroke (yes/no)
Measured: From the index dobutamine stress echocardiography date until first stroke, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
planned coronary revascularisation
planned coronary revascularisation (yes/no)
Measured: From the index dobutamine stress echocardiography date until first planned coronary revascularisation, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
unplanned coronary revascularisation
unplanned coronary revascularisation (yes/no)
Measured: From the index dobutamine stress echocardiography date until first unplanned coronary revascularisation, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start7 Jun 2019
- Primary completion4 Nov 2023
- Study completionOct 2028 (estimated)
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 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
- Retrospective
- Enrolment
- 2,281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton Keynes University Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Attila Kardos, MD, PhD, FRCP, FESC, Principal investigator, Milton Keynes University Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432620
- Sponsor's protocol ID
- MKUH-RD-008
- Other IDs
- 249297, 19/YH/0159, 22/CAG/0034
- Acronym
- FINESSE
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, disclosure-controlled individual participant data will be made available to external researchers for accredited research purposes / research in the public interest. Data shared will be limited to the minimum necessary variables to meet the approved research purpose and will be processed to reduce re-identification risk (e.g., de-identification and disclosure control, including suppression/controls where needed). Data will only be released once the approvals and agreements described in the access criteria are in place.
Publications
Ihekwaba U, Bennasar M, Johnson N, Garces NS, West H, Price B, Khoo J, Squire I, Chan K, Kardos A. The FINESSE (Artificial Intelligence Stress Echo) study to develop and validate machine learning-based model to improve risk prediction in patients undergoing stress echocardiography for the assessment of inducible myocardial ischaemia (FINESSE Protocol). Eur Heart J Imaging Methods Pract. 2026 Aug 24;4(3):qyag143. doi: 10.1093/ehjimp/qyag143. eCollection 2026 Aug.
PubMed 42695072
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction Model in Patients With Suspected Coronary Artery Disease Based on Contemporary Stress Echocardiography Data Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07432620
- Acronym / sponsor ID
- FINESSE / MKUH-RD-008
- Conditions
- Coronary Artery Disease, Chest Pain, Myocardial Ischemia, Angina Pectoris, Myocardial Infarction (MI)
- Keywords
- Dobutamine stress echocardiography, Stress echocardiography, Coronary artery disease, Myocardial ischemia, Chest pain, Risk stratification, Machine learning, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,281 participants (actual)
- Lead sponsor
- Milton Keynes University Hospital NHS Foundation TrustOther government
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 4 Nov 2023 (actual)
- Study completion
- Oct 2028 (estimated)
- First posted
- 25 Feb 2026 (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.
The goal of this observational study is to learn whether combining stress echocardiography (stress echo) results with routine clinical information can better predict important heart outcomes in adults (18+) with chest pain who were assessed for suspected coronary artery disease.
The main questions it aims to answer are:
Can an artificial intelligence / machine learning model using stress echo findings plus clinical factors (such as blood pressure, diabetes, smoking, other health conditions, medications, and body measurements) predict major heart-related events (such as heart attack, stroke, death related to heart disease, or the need for coronary procedures) more accurately than stress echo results alone?
Can the model help identify which patients are most likely to benefit from further invasive assessment and possible coronary revascularisation (for example, a stent or bypass surgery)?
Which combination of stress echo measurements and clinical factors contributes most to risk prediction?
Participants will:
Not be asked to attend extra visits or have additional tests for this study.
Have their existing stress echo reports and routinely collected hospital record data analysed (approximately 3,000 people who previously had dobutamine stress echo at Milton Keynes University Hospital).
In some cases, if outcomes are not fully available from hospital records, the research team may check additional sources (such as GP records, or contacting the patient if appropriate) to confirm whether a major heart-related event occurred.
Detailed description
This is a single-centre, retrospective observational study using an existing dataset of pharmacological (dobutamine) stress echocardiography (SE) reports generated within Milton Keynes University Hospital over approximately 15 years, starting from 2002. The SE dataset comprises reports/letters produced by a single, experienced clinician, which reduces inter-observer variability and supports consistent interpretation across the cohort.
Data sources and cohort construction
SE reports (in document format) will be converted into a structured research database. A computer science team will develop a generalisable approach to extract structured variables from the clinical SE reports, building on prior proof-of-concept work demonstrating feasibility of converting these reports into a database.
The dataset includes clinical variables (e.g., cardiovascular risk factors, comorbidities, prescribed medications, and anthropometrics) alongside SE-derived measures (including ischaemia detection and wall motion scoring at rest and peak stress).
Stress echocardiography technique (context for imaging-derived variables)
The study dataset reflects contemporary dobutamine SE practice at MKUH, with contrast-enhanced imaging used in the majority of cases (SonoVue contrast with rota pump infusion equipment). Studies were performed predominantly on Philips echocardiography systems, with image acquisition across standard stages (resting, intermediate, peak stress, and recovery) and standard views (apical 4-, 2-, and 3-chamber; parasternal long- and short-axis). Reporting used dedicated platforms enabling stage-by-stage comparison.
Outcome ascertainment and linkage
Following database completion, a research nurse will query the hospital Electronic Data Management system to ascertain major adverse cardiovascular events (MACE) for the cohort. Where outcomes cannot be confirmed from hospital systems (e.g., patients no longer served by the hospital), missing outcome information will be explored via primary care physician contact and/or patient contact as appropriate.
Data processing, quality checks, and handling missingness
Extracted data will undergo cleaning prior to analysis. Natural Language Processing (NLP) and feature engineering approaches will be used to transform extracted information into model-ready features. As part of preprocessing, data fields will be checked for completeness and consistency before modelling. Missing outcome data will be addressed through the external outcome checks described above.
Statistical / machine learning approach and internal validation
After preprocessing, subset feature selection methods will be applied to identify the most informative predictors for risk classification. Supervised learning will be used to discriminate between lower-risk cases and cases requiring further investigation, with additional modelling approaches (including regression techniques) planned to support quantification of disease stage in abnormal cases. Overfitting will be mitigated through use of techniques robust to overfitting (e.g., ensemble methods) and internal validation using k-fold cross-validation (five folds), ensuring separation of training and validation data.
Sample size and additional analyses
The study will utilise the available full dataset (approximately 3,000 patients) to maximise model development and internal validation. A cost analysis is also planned using the available data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dobutamine Stress Echocardiography Cohort | – | Diagnostic Test: Dobutamine Stress EchocardiographyAdults who previously underwent clinically indicated dobutamine stress echocardiography at Milton Keynes University Hospital for assessment of chest pain/suspected coronary artery disease. Stress echocardiography findings and routinely collected clinical information from existing records will be extracted and linked to subsequent cardiovascular outcomes captured through routine care data. Analyses will examine differences in outcomes between participants with normal versus abnormal stress echocardiography findings (and across predicted risk strata generated by the model). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single-centre retrospective cohort drawn from Milton Keynes University Hospital records, consisting of approximately 3,000 adults who underwent clinically indicated pharmacological (dobutamine) stress echocardiography for assessment of chest pain / suspected coronary artery disease (dataset dating back to 2002, covering ~15 years of reports). Stress echocardiography report variables are extracted and linked to routine clinical outcome data for analysis.
Key inclusion criteria (3 listed)
- Age 18 years or older at the time of the index stress echocardiography.
- Referred for pharmacological (dobutamine) stress echocardiography at Milton Keynes University Hospital for assessment of suspected coronary artery disease / chest pain.
- Stress echocardiography report available in the hospital dataset for data extraction and conversion into a structured database.
Key exclusion criteria (4 listed)
- Age under 18 years at the time of the index stress echocardiography.
- No available/usable stress echocardiography report for extraction into the study database.
- Unable to link the record to follow-up outcome information using routine hospital systems (with attempted supplementary checks where needed).
- Patients who have registered a National Data Opt-out and are therefore not eligible for use of their confidential patient information for research/secondary purposes in this study.
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 |
|---|---|---|
| Dobutamine Stress EchocardiographyClinically indicated dobutamine stress echocardiography performed as part of routine care for assessment of suspected coronary artery disease/chest pain. Echocardiographic images acquired at rest and during incremental dobutamine stress (with recovery imaging) are interpreted for inducible ischaemia and regional wall motion abnormalities (including wall motion scoring). Contrast enhancement may be used where needed to optimise endocardial border definition. For this observational study, no additional tests or procedures are performed beyond standard clinical practice; existing stress echocardiography reports and associated routine clinical data are analysed retrospectively. | Diagnostic test | Dobutamine Stress Echocardiography Cohort |
Primary outcome
Major adverse cardiovascular events (MACE) - composite
Time frame: From the index dobutamine stress echocardiography date until the first major adverse cardiovascular event or death (whichever occurs first), or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
Composite of fatal myocardial infarction, non-fatal myocardial infarction, stroke, planned coronary revascularisation, and unplanned coronary revascularisation. (yes/no)
5 secondary outcomes
fatal myocardial infarction
Time frame: From the index dobutamine stress echocardiography date until fatal myocardial infarction (MI as cause of death), or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
non-fatal myocardial infarction
Time frame: From the index dobutamine stress echocardiography date until first non-fatal myocardial infarction, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
stroke
Time frame: From the index dobutamine stress echocardiography date until first stroke, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
planned coronary revascularisation
Time frame: From the index dobutamine stress echocardiography date until first planned coronary revascularisation, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
unplanned coronary revascularisation
Time frame: From the index dobutamine stress echocardiography date until first unplanned coronary revascularisation, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
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 25 Feb 2026.
- Derived from this study: PubMed 42695072Ihekwaba U, Bennasar M, Johnson N, Garces NS, West H, Price B, Khoo J, Squire I, Chan K, Kardos A. The FINESSE (Artificial Intelligence Stress Echo) study to develop and validate machine learning-based model to improve risk prediction in patients undergoing stress echocardiography for the assessment of inducible myocardial ischaemia (FINESSE Protocol). Eur Heart J Imaging Methods Pract. 2026 Aug 24;4(3):qyag143. doi: 10.1093/ehjimp/qyag143. eCollection 2026 Aug.
- Individual participant dataSharing planned: Yes. De-identified, disclosure-controlled individual participant data will be made available to external researchers for accredited research purposes / research in the public interest. Data shared will be limited to the minimum necessary variables to meet the approved research purpose and will be processed to reduce re-identification risk (e.g., de-identification and disclosure control, including suppression/controls where needed). Data will only be released once the approvals and agreements described in the access criteria are in place.
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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.
Attila Kardos, MD, PhD, FRCP, FESC principal investigator
Milton Keynes University Hospital NHS Foundation Trust
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 and Chest Pain, run by Milton Keynes University Hospital NHS Foundation 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 25 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?
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?
Major adverse cardiovascular events (MACE) - composite (time frame: From the index dobutamine stress echocardiography date until the first major adverse cardiovascular event or death (whichever occurs first), or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).). 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 NCT07432620, 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 25 Feb 2026.