Artificial Intelligence for Reconstruction of Echocardiography Studies

NCT07093918 | Not Yet Recruiting

• 1 other identifier: 2024CAR136
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiotoxicity

Keywords

Echocardiography; Artificial intelligence; Reconstruction; Cardiovascular magnetic resonance (CMR); Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Comparison of LVEF measured by V-echo and L-echo in comparison to CMR at baseline imaging

  2 years

Secondary Outcomes (3)

• Comparison of V-echo and L-echo versus CMR volumetric quantification

  2 years

• Comparison of V-echo and L-echo versus C-echo volumetric quantification

  2 years

• Patient and staff acceptability surveys

  2 years

Study Arms (1)

Clinical utility of V-echo and L-echo

Evaluate the clinical utility of V-echo and L-echo against standard practice in patients who have received potentially cardiotoxic chemotherapy.

Other: V-echo; Other: L-echo

Interventions

V-echo OTHER

Imaging system

Clinical utility of V-echo and L-echo

L-echo OTHER

Imaging system

Clinical utility of V-echo and L-echo

Eligibility Criteria

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

Study Population

Patients will be identified after referral by the oncology team for routine echocardiography surveillance following the prescription of potentially cardiotoxic chemotherapy

You may qualify if:

• Aged 18 years or older
• Received potentially cardiotoxic chemotherapy
• Participant requires echocardiography surveillance as standard current practice

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• VentriPoint Diagnostics Ltd.: collaborator

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Sandeep Hothi

  Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandeep Hothi

CONTACT

01902; s.hothi@nhs.net

Lorraine Jacques

CONTACT

01902 695065; lorraine.jacques@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 1, 2030
• Last Updated: February 11, 2026

Record last verified: 2026-02