Quantitative Stress Echocardiography to Diagnose Myocardial Ischaemia (DEVISE)

University Hospital of Wales

Status: Unknown

Conditions: Ischemia, Myocardial

Treatments: Diagnostic Test: Deformation imaging

Study type: Observational

Funder types: Other

Identifiers

NCT03659526

IRAS Project ID 136434

Details and patient eligibility

About

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.

Enrollment: 390 estimated patients

Sex: All

Ages: 20 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

390 participants in 4 patient groups

Control

Description:

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

Treatment:

Diagnostic Test: Deformation imaging

Deformation imaging

Description:

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.

Treatment:

Diagnostic Test: Deformation imaging

High p(CAD)

Description:

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

Treatment:

Diagnostic Test: Deformation imaging

All comers

Description:

Probability of severe disease ranging from 15 to 85%.

Treatment:

Diagnostic Test: Deformation imaging