Quantitative Stress Echocardiography to Diagnose Myocardial Ischaemia

Ischemia, Myocardial Clinical Trial

— DEVISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03659526
• Other study ID #: IRAS Project ID 136434
• Status: Recruiting
• Start date: January 21, 2016
• Est. completion date: October 31, 2021

Study information

• Verified date: September 2018
• Source: University Hospital of Wales
• Contact: Imran D Sunderji
• Phone: +441482 875875
• Email: imran.sunderji[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Ischemia, Myocardial
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Deformation imaging
Deformation parameters derived using myocardial velocity imaging or speckle tracking

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Sweden	Danderyd Hospital	Stockholm
United Kingdom	University Hospital Wales	Cardiff
United Kingdom	Castle Hill Hospital	Cottingham

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital of Wales	Danderyd Hospital, Hull and East Yorkshire Hospitals NHS Trust, Leuven University, Universitat Pompeu Fabra

Countries where clinical trial is conducted

Belgium,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of quantitative measures of dobutamine stress echocardiography	Echocardiographic measurements of segmental myocardial velocity, strain, strain rate and wall motion scoring referenced against measurements derived from coronary angiography.	18 months
Secondary	Lowest dose of dobutamine to provoke measurable marker of inducible myocardial ischaemia	Using modelling techniques applied predict lowest dose of dobutamine to maintain diagnostic accuracy	18 months
Secondary	Diagnostic accuracy of using machine learning to interpret multiparametric and multidimensional datasets to diagnose myocardial ischaemia	Use 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).	18 months