Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol

• Conditions: Cancer; Cardiotoxicity

• Registration Number: NCT04877899
• Lead Sponsor: Ultromics Ltd

Brief Summary

This study aims to compare conventionally acquired Left Ventricle Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS) data to Artificial Intelligence (AI) driven automated processing of 2 dimensional contrast and 2 dimensional non-contrast resting transthoracic echocardiograms for application in the assessment of patients undergoing chemotherapy with cardiotoxic drugs. This is a single-centre retrospective study which utilizes echocardiographic DICOM image and meta-data datasets received from a Canadian site. Data processed using the AI driven automated processing will be compared to conventionally acquired LVEF and GLS measurements and results will be analysed to determine accuracy and precision.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-08
• Primary Completion: 2021-03-31
• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Normal EF and no regional wall motion abnormalities prior to starting chemotherapy treatment.
• Follow-up EF measurements available for at least 1 year during the treatment period.
• Follow-up EF measurements for at least 1 year during the treatment period.

Exclusion Criteria

• Age < 18 years
• Inadequate image quality (as determined by the Ultromics Operators Quality Control process)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.	Follow up (up to 1 year)	Measurements will be assessed using bias and 95% confidence internals on bias. Regression coefficients, comparative statistics and equivalence testing might also be employed as a comparison measure for this objective.
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.	Follow up (up to 1 year)	Measurements shall be compared using bias and 95% confidence intervals on bias. Regression coefficients and comparative statistics will be employed for this objective.

Trial Locations

Locations (1)

Mazankowski Alberta Heart Institute; 🇨🇦 Edmonton, Alberta, Canada