Skip to content

Quantitative Stress Echocardiography to Diagnose Myocardial Ischaemia

Development, Validation and Implementation of a New Quantitative Stress Echocardiographic Test for Myocardial Ischaemia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03659526
Acronym
DEVISE
Enrollment
390
Registered
2018-09-06
Start date
2016-01-21
Completion date
2021-10-31
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia, Myocardial

Keywords

Myocardial velocity imaging, Strain, Strain rate, Speckle tracking, Deformation, Quantitative, Echocardiography, Machine learning

Brief summary

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.

Interventions

DIAGNOSTIC_TESTDeformation imaging

Deformation parameters derived using myocardial velocity imaging or speckle tracking

Sponsors

Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
Universitat Pompeu Fabra
CollaboratorOTHER
Hull University Teaching Hospitals NHS Trust
CollaboratorOTHER_GOV
Danderyd Hospital
CollaboratorOTHER
University Hospital of Wales
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of quantitative measures of dobutamine stress echocardiography18 monthsEchocardiographic measurements of segmental myocardial velocity, strain, strain rate and wall motion scoring referenced against measurements derived from coronary angiography.

Secondary

MeasureTime frameDescription
Lowest dose of dobutamine to provoke measurable marker of inducible myocardial ischaemia18 monthsUsing modelling techniques applied predict lowest dose of dobutamine to maintain diagnostic accuracy
Diagnostic accuracy of using machine learning to interpret multiparametric and multidimensional datasets to diagnose myocardial ischaemia18 monthsUse modelling to combine pre-test probabilities (based on risk factors such as age), physiological factors (e.g., heart rate) that are associated with longitudinal function and data derived throughout the cardiac cycle (i.e., based on analysis of velocity or strain curves and not just a single value like peak velocity or strain).

Countries

Belgium, Sweden, United Kingdom

Contacts

Primary ContactImran D Sunderji
imran.sunderji@nhs.net+441482 875875
Backup ContactAlan G Fraser

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026