Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07432620

Artificial Intelligence Stress Echo (FINESSE) Project

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dobutamine stress echocardiography

Diagnostic 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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

    Fatal MI (yes/no)

  2. 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).

    non-fatal MI (yes/no)

  3. 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).

    stroke (yes/no)

  4. 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).

    planned coronary revascularisation (yes/no)

  5. 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).

    unplanned coronary revascularisation (yes/no)

Sponsors and collaborators

Lead sponsor

Milton Keynes University Hospital NHS Foundation Trust

Other Gov

Registry information

Official study title

Risk Prediction Model in Patients With Suspected Coronary Artery Disease Based on Contemporary Stress Echocardiography Data Using Artificial Intelligence

Acronym: FINESSE

Important dates

Study start
2019
Primary completion
2023
Study completion
2028
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.