Quantitative Stress Echocardiography to Diagnose Myocardial Ischaemia

NCT ID: NCT03659526

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-21

Study Completion Date

2021-10-31

Brief Summary

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Patients with chest pain on exertion need a reliable non-invasive test to identify if they have inducible myocardial ischaemia. This would reduce the use of diagnostic coronary arteriography, avoid its risks and costs, and guide clinical decisions. Conventional stress echocardiography has poor reproducibility because it relies on qualitative and subjective interpretation. Quantitative approaches based on precise and reliable measurements of myocardial velocity, strain, strain rate and global longitudinal strain have been shown to be able to accurately diagnose myocardial ischaemia. A more accurate test using myocardial velocity imaging was not implemented by ultrasound vendors although it provided an objective measurement of myocardial functional reserve on a continuous scale from normality to severe ischaemia.

The investigators propose an original approach to create a diagnostic software tool that can be used in routine clinical practice. The investigators will extract and compare quantitative data obtained through myocardial velocity imaging and speckle tracking in subjects who undergo dobutamine stress echocardiography.

The data will be analysed using advanced computational mathematics including multiple kernel learning and joint statistics applied to multivariate data across multiple dimensions (including velocity, strain and strain rate traces). This approach will be validated against quantitative coronary arteriography and fractional flow reserve. The results will be displayed as parametric images and placed into a reporting tool. The output will determine the presence and severity of myocardial ischaemia. These new tools will have the capacity for iterative learning so that the precision of the diagnostic conclusions can be continuously refined.

Detailed Description

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Conditions

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Ischemia, Myocardial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Healthy volunteers or if they have had normal invasive or CT coronary arteriography or other functional imaging test

Deformation imaging

Intervention Type DIAGNOSTIC_TEST

Deformation parameters derived using myocardial velocity imaging or speckle tracking

Deformation imaging

Significant coronary disease (diameter stenosis \>50%) has been diagnosed on arteriography or on CT angiography. Fractional flow reserve will be measured as the reference criterion.

Deformation imaging

Intervention Type DIAGNOSTIC_TEST

Deformation parameters derived using myocardial velocity imaging or speckle tracking

High p(CAD)

Intermediate-to-high probability of significant epicardial coronary disease (\>50%).

Deformation imaging

Intervention Type DIAGNOSTIC_TEST

Deformation parameters derived using myocardial velocity imaging or speckle tracking

All comers

Probability of severe disease ranging from 15 to 85%.

Deformation imaging

Intervention Type DIAGNOSTIC_TEST

Deformation parameters derived using myocardial velocity imaging or speckle tracking

Interventions

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Deformation imaging

Deformation parameters derived using myocardial velocity imaging or speckle tracking

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Chest pain, chest pain equivalent

Exclusion Criteria

* acute coronary syndrome with elevated troponin, severe heart valve disease, uncontrolled hypertension (resting SBP \>200mmHg), cardiomyopathy, contraindication to dobutamine, pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

Universitat Pompeu Fabra

OTHER

Sponsor Role collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role collaborator

University Hospital of Wales

OTHER

Sponsor Role lead

Responsible Party

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Professor Alan G Fraser

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan G Fraser

Role: PRINCIPAL_INVESTIGATOR

University Hospital Wales

Locations

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UZ Leuven

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

Danderyd Hospital

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

University Hospital Wales

Cardiff, , United Kingdom

Site Status RECRUITING

Castle Hill Hospital

Cottingham, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Belgium Sweden United Kingdom

Central Contacts

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Imran D Sunderji

Role: CONTACT

+441482 875875

Alan G Fraser

Role: CONTACT

Facility Contacts

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Jens Voigt

Role: primary

Reidar Winter

Role: primary

Alan G Fraser

Role: primary

Imran D Sunderji

Role: primary

Other Identifiers

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IRAS Project ID 136434

Identifier Type: -

Identifier Source: org_study_id

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