Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol

NCT04877899 | Unknown FDA Device

• 1 other identifier: COL-04
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity; Cancer

Outcome Measures

Primary Outcomes (4)

• Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.

  Measurements shall be compared using bias and 95% confidence intervals on bias. Regression coefficients and comparative statistics will be employed for this objective.

  Baseline

• Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.

  Measurements shall be compared using bias and 95% confidence intervals on bias. Regression coefficients and comparative statistics will be employed for this objective.

  Follow up (up to 1 year)

• Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.

  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.

  Baseline

• Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.

  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.

  Follow up (up to 1 year)

Interventions

EchoGo DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ultromics Ltd: lead
• Mazankowski Alberta Heart Institute: collaborator

Study Sites (1)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2J2, Canada

Location

MeSH Terms

Conditions

Cardiotoxicity; Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Harald Becher

  Mazankowski Alberta Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 7, 2021
• Study Start: October 8, 2020
• Primary Completion: March 31, 2021
• Study Completion: November 30, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

CA (1)