Artificial Intelligence for Reconstruction of Echocardiography Studies
ConditionCardiotoxicity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Royal Wolverhampton Hospitals NHS Trust
About this trial
To investigate the clinical utility of both 3D and 2D artificial intelligence reconstruction echocardiography (V-echo and L-echo) assessment against conventional echocardiography and clinical cardiovascular magnetic resonance (CMR) imaging for the characterisation of cardiac function and detection of cardiotoxicity in patients receiving chemotherapy.
Diagnostic accuracy of V-echo and L-echo for quantification of cardiac chamber sizes and systolic function (left ventricular ejection fraction (LVEF) and strain analyses) versus conventional echocardiography (C-echo) and CMR; workflow measures including imaging temporal measures of image acquisition, registration and analysis versus conventional approaches; survey of markers of acceptability by patients and sonographers; cost effectiveness analysis of V-echo and L-echo versus conventional echocardiography; assessment of the relationship between 3D strain parameters derived from V-echo data, 2D strain parameters derived from L-echo and correlation with conventional markers of cardiac function, namely LVEF and global longitudinal strain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older
Received potentially cardiotoxic chemotherapy
Participant requires echocardiography surveillance as standard current practice
Disqualifiers
Below the age of 18 years old
Inability to give informed consent
Implanted cardiac devices
Not having received cardiotoxic chemotherapy. Ineligible patients and patients not wishing to take part will be excluded, the reasons for this will be recorded and baseline CONSORT demographics noted including age, gender, ethnicity.
Trial population
Patients will be identified after referral by the oncology team for routine echocardiography surveillance following the prescription of potentially cardiotoxic chemotherapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
V-echo
Other interventionImaging system
L-echo
Other interventionImaging system
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Clinical utility of V-echo and L-echo2 interventions
Trial outcomes
Primary outcomes
1
Comparison of LVEF measured by V-echo and L-echo in comparison to CMR at baseline imaging
Time frame
2 yearsSecondary outcomes
1
Comparison of V-echo and L-echo versus CMR volumetric quantification
Cardiac volumes (LV, RV, LA and RA) measured by V-echo and L-echo versus CMR at baseline
Time frame
2 years2
Comparison of V-echo and L-echo versus C-echo volumetric quantification
This will encompass a composite of diagnostic accuracy, time savings, and avoidance of additional imaging (CMR or contrast echo) into impacts on capacity and cost to achieve this.
Time frame
2 years3
Patient and staff acceptability surveys
Opinion and experience of the use of AI systems in echocardiography diagnostic services will be gained from both patient and staff perspectives
Time frame
2 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Royal Wolverhampton Hospitals NHS Trust
Lead sponsor
VentriPoint Diagnostics Ltd.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: