Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol

NCT04877899 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2021-09-05

No results posted yet for this study

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

DEVICE

EchoGo

EchoGo 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.

Sponsors & Collaborators

  • Mazankowski Alberta Heart Institute

    collaborator UNKNOWN
  • Ultromics Ltd

    lead INDUSTRY

Principal Investigators

  • Harald Becher · Mazankowski Alberta Heart Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2021-03-31
Completion
2021-11-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877899 on ClinicalTrials.gov