NCT04193475

Brief 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. 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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

November 18, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

November 22, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 17, 2026

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

November 18, 2019

Last Update Submit

February 12, 2026

Conditions

Cardiovascular DiseasesIschaemic Heart Disease

Keywords

Chest painAnginaDeformation imagingTissue doppler imagingStrainVelocity

Outcome Measures

Primary Outcomes (1)

  • Inducible myocardial ischaemia

    Diagnostic performance of the machine learning classifier for the detection of inducible myocardial ischaemia as determined by reduced coronary flow reserve

    3 years

Secondary Outcomes (4)

  • Workload

    3 years

  • Velocity

    3 years

  • Strain rate

    3 years

  • Strain

    3 years

Study Arms (1)

Chest pain

Individuals presenting with chest pain requiring a stress echocardiogram.

Other: Analysis

Interventions

AnalysisOTHER

No intervention planned. Novel analysis of echocardiographic data.

Chest pain

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Clinically suitable for stress echocardiography examination

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castle Hill Hospital

Cottingham, HU165JQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseChest PainAngina PectorisSprains and Strains

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Central Study Contacts

Imran Sunderji, MBBS

CONTACT

07540844481imran.sunderji@nhs.net

Study Design

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

Study Record Dates

First Submitted

November 18, 2019

First Posted

December 10, 2019

Study Start

November 22, 2019

Primary Completion

August 1, 2021

Study Completion

March 1, 2026

Last Updated

February 17, 2026

Record last verified: 2025-03

Locations

GB(1)