Quantitative Stress Echocardiography to Diagnose Myocardial Ischaemia (DEVISE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Ischemia, Myocardial
• Intervention / Treatment: Diagnostic test: Deformation imaging

• Study Type: Observational
• Enrollment (Anticipated): 390

Contacts and Locations

• Study Contact: Name: Imran D Sunderji; Phone Number: +441482 875875; Email: imran.sunderji@nhs.net
• Study Contact Backup: Name: Alan G Fraser

Study Locations

• Belgium
  • Leuven, Belgium
    • Not yet recruiting
    • UZ Leuven
    • Contact: Jens Voigt
• Sweden
  • Stockholm, Sweden
    • Not yet recruiting
    • Danderyd Hospital
    • Contact: Reidar Winter
• United Kingdom
  • Cardiff, United Kingdom
    • Recruiting
    • University Hospital Wales
    • Contact: Alan G Fraser
    • Principal Investigator: Alan G Fraser
  • Cottingham, United Kingdom
    • Not yet recruiting
    • Castle Hill Hospital
    • Contact: Imran D Sunderji
    • Principal Investigator: Imran D Sunderji

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Secondary care referrals

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Healthy volunteers or if they have had normal invasive or CT coronary arteriography or other functional imaging test	Diagnostic test: Deformation imaging; 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.	Diagnostic test: Deformation imaging; Deformation parameters derived using myocardial velocity imaging or speckle tracking
High p(CAD); Intermediate-to-high probability of significant epicardial coronary disease (>50%).	Diagnostic test: Deformation imaging; Deformation parameters derived using myocardial velocity imaging or speckle tracking
All comers; Probability of severe disease ranging from 15 to 85%.	Diagnostic test: Deformation imaging; Deformation parameters derived using myocardial velocity imaging or speckle tracking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital of Wales
• Collaborators: Hull University Teaching Hospitals NHS Trust; Danderyd Hospital; Universitat Pompeu Fabra; Leuven University
• Investigators: Principal Investigator: Alan G Fraser, University Hospital Wales

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2016
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: September 2, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 2, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Echocardiography; Speckle tracking; Machine learning; Strain; Myocardial velocity imaging; Strain rate; Deformation; Quantitative
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: IRAS Project ID 136434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No