Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol

NCT ID: NCT04877899

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-08

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiotoxicity Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mazankowski Alberta Heart Institute

UNKNOWN

Sponsor Role collaborator

Ultromics Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Harald Becher

Role: PRINCIPAL_INVESTIGATOR

Mazankowski Alberta Heart Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COL-04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HeartGuide: Preliminary Study
NCT05490303 UNKNOWN NA
AI ECHO INSIGHT RCT for Automated Echo Reporting
NCT07229300 ENROLLING_BY_INVITATION NA
Prognostic Role of AI-Echo
NCT07009639 RECRUITING
The Echodynamic Approach
NCT06859047 RECRUITING