Clinical trial NCT04877899: Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol
Official title: Mazankowski - Echo Go Discovery Protocol Retrospective LVEF/GLS Comparison
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotoxicity
Cancer
Lead sponsor: Ultromics Ltd
Sponsor class: INDUSTRY
Collaborators: name: Mazankowski Alberta Heart Institute
First posted: 2021-05-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Data included for analysis in this study will be retrospective data from male and female patients aged 18 years or above who received an echocardiogram for baseline and follow-up of cardiotoxic agent management, who agreed to participate in the echocardiography registry of the MAHI, and who have already provided a written consent that their anonymized imaging data can be used to advance echocardiographic assessment of LV function.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.
timeFrame: Baseline
measure: Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.
timeFrame: Follow up (up to 1 year)
measure: Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.
timeFrame: Baseline
measure: Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.
timeFrame: Follow up (up to 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
state: Alberta
Study officials:
affiliation: Mazankowski Alberta Heart Institute
name: Harald Becher
role: PRINCIPAL_INVESTIGATOR
References: