NCT07432620

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,281

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2019Oct 2028

Study Start

First participant enrolled

June 7, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Expected
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4.4 years

First QC Date

February 9, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

Dobutamine stress echocardiographyStress echocardiographyCoronary artery diseaseMyocardial ischemiaChest painRisk stratificationMachine learningArtificial intelligenceCardiovascular risk predictionMajor adverse cardiovascular eventsStroke

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    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

    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

    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

    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

    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).

Study Arms (1)

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).

Diagnostic Test: Dobutamine Stress Echocardiography

Interventions

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.

Dobutamine Stress Echocardiography Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton Keynes University Hospital

Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseChest PainMyocardial IschemiaAngina PectorisMyocardial InfarctionStroke

Interventions

Echocardiography, Stress

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Attila Kardos, MD, PhD, FRCP, FESC

    Milton Keynes University Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 25, 2026

Study Start

June 7, 2019

Primary Completion

November 4, 2023

Study Completion (Estimated)

October 1, 2028

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Requests may be submitted once the research proposal is ready for review. A decision is expected within \~21 days of receipt of a complete application (including all required supporting documents and agreements). Approved data will be transferred after sign-off and completion of the Third Party Agreement, and availability will be case-by-case subject to the database being maintained and the governance safeguards remaining appropriate.
Access Criteria
Access is not open access. Researchers must apply via the Trust's R\&D contact route with full details of the proposed research, justification, and the specific data required. The applicant must be the Principal Investigator for the proposed project and provide evidence of suitability (e.g., CV and GCP certificate where relevant) and enter into the Trust's third-party data access agreement. Requests are reviewed through the Trust governance process, including confirmation that appropriate peer review, patient/public involvement and ethics/regulatory approvals are in place where required. Final information governance sign-off is required before release. Transfers are completed by the database/data custodian and recorded (data transferred, format, and date). NOTE: Some items (incl. outcome data received from NHS England) may need an MKUH-NHSE contract amendment to name the requester and may incur charges. Contact MKUH R\&D: research@mkuh.nhs.uk for further information.

Locations