CardiotoxicityNCT04877899
Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol
An observational study of Cardiotoxicity and Cancer, run by Ultromics Ltd at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity, Cancer
- What is being tested?
- EchoGo
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 8 Oct 2020to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age < 18 years
- Inadequate image quality (as determined by the Ultromics Operators Quality Control process)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mazankowski - Echo Go Discovery Protocol Retrospective LVEF/GLS Comparison
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
- Being tested
- EchoGo
- Medical subject headings
- Cardiotoxicity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoGoDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow up (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start8 Oct 2020
- Primary completion31 Mar 2021
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ultromics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mazankowski Alberta Heart Institute
- Responsible party
- Sponsor
- Investigators
- Harald Becher, Principal investigator, Mazankowski Alberta Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877899
- Sponsor's protocol ID
- COL-04
- Status last verified
- Sep 2021
- First submitted
- 22 Apr 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mazankowski - Echo Go Discovery Protocol Retrospective LVEF/GLS Comparison
- ClinicalTrials.gov ID
- NCT04877899
- Acronym / sponsor ID
- COL-04
- Conditions
- Cardiotoxicity, Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ultromics LtdIndustry (pharma, biotech, devices)
- Collaborators
- Mazankowski Alberta Heart Institute
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Age < 18 years
- Inadequate image quality (as determined by the Ultromics Operators Quality Control process)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchoGoEchoGo 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. | Device | – |
Primary outcome
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.
Time frame: Baseline
Measurements shall be compared using bias and 95% confidence intervals on bias. Regression coefficients and comparative statistics will be employed for this objective.
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.
Time frame: Follow up (up to 1 year)
Measurements shall be compared using bias and 95% confidence intervals on bias. Regression coefficients and comparative statistics will be employed for this objective.
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.
Time frame: Baseline
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.
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.
Time frame: Follow up (up to 1 year)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Becher principal investigator
Mazankowski Alberta Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Cancer, run by Ultromics Ltd at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition. (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.