Quantitative Stress Echocardiography to Diagnose Myocardial Ischaemia

NCT03659526 | Unknown

• 1 other identifier: IRAS Project ID 136434
• Study Type: observational
• Target: 390
• Locations: 3 countries
• Sites: 4

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.

Conditions

Ischemia, Myocardial

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Lowest dose of dobutamine to provoke measurable marker of inducible myocardial ischaemia

  18 months

• Diagnostic accuracy of using machine learning to interpret multiparametric and multidimensional datasets to diagnose myocardial ischaemia

  18 months

Study Arms (4)

Control

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

Diagnostic Test: Deformation imaging

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

High p(CAD)

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

Diagnostic Test: Deformation imaging

All comers

Probability of severe disease ranging from 15 to 85%.

Diagnostic Test: Deformation imaging

Interventions

Deformation imaging DIAGNOSTIC_TEST

Deformation parameters derived using myocardial velocity imaging or speckle tracking

All comers; Control; Deformation imaging; High p(CAD)

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care referrals

You may qualify if:

• Chest pain, chest pain equivalent

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Wales: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Universitat Pompeu Fabra: collaborator
• Hull University Teaching Hospitals NHS Trust: collaborator
• Danderyd Hospital: collaborator

Study Sites (4)

UZ Leuven

Leuven, Belgium

NOT YET RECRUITING

Danderyd Hospital

Stockholm, Sweden

NOT YET RECRUITING

University Hospital Wales

Cardiff, United Kingdom

RECRUITING

Castle Hill Hospital

Cottingham, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Sprains and Strains

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries

Study Officials

• Alan G Fraser

  University Hospital Wales

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran D Sunderji

CONTACT

+441482 875875; imran.sunderji@nhs.net

Alan G Fraser

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 6, 2018
• Study Start: January 21, 2016
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2021
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

SE (1); BE (1); GB (2)