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UnknownNCT04877899

Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol

Mazankowski - Echo Go Discovery Protocol Retrospective LVEF/GLS Comparison

Status
Unknown
Phase
Study type
Observational
Enrollment
250 (estimated)
Sponsor
Ultromics Ltd · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEEchoGoEchoGo Core is a stand-alone software application. Echocardiograms should be acquired under the supervision of a physician and standard clinical protocols which includes focused apical 2, 3 and 4 chamber views. The results contain calculated measurements that will be returned to the interpreting physician. These results are intended as an additional input to standard diagnostic pathways and should only be used by a board-certified cardiologist/physician. EchoGo Core is intended to be used for the quantification and reporting of results of cardiovascular function to support physician diagnosis. EchoGo Core is indicated for use in adult populations.

Timeline

Start date
2020-10-08
Primary completion
2021-03-31
Completion
2021-11-30
First posted
2021-05-07
Last updated
2021-09-05

Locations

1 site across 1 country: Canada

Regulatory

Source: ClinicalTrials.gov record NCT04877899. Inclusion in this directory is not an endorsement.