TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
NCT ID: NCT06310330
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-03-08
2026-12-31
Brief Summary
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Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice.
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Detailed Description
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CTRCD, often named cardiotoxicity, usually refers to myocardial dysfunction and heart failure developing after administration of potentially cardiotoxic therapy. By precise diagnostics, adequate treatment can be started early to prevent heart failure and unnecessary discontinuation of the potential life-saving cancer treatment may be avoided. However, guideline advocated analyses of cardiac function (EF and GLS) by echocardiography are time consuming and many operators base their semi-quantitative estimates on visual assessment. Furthermore, test-retest variability for both EF and GLS are significant and may exceed the guideline recommended cut-offs for identification of cancer therapy-related cardiovascular toxicity.
The study will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomized design. The study will also evaluate if novel tools for improved standardization of recordings and automated measurements of relevant measurements as ejection fraction (EF) and global longitudinal strain (GLS) can improve the diagnostic precision.
Breast cancer patients referred for follow-up at the echocardiography will be included.
Patients will be randomized 1:1 to A) examinations with two- and three-dimensional echocardiography including all central measures of cardiac size and function measured by sonographers as recommended by the European guidelines and as clinical practice or B) echocardiographic examinations focusing on the ventricles.
Subpopulations will undergo additional testing with serial echocardiographic examinations by four operators on the same day with and without use of novel tools for improved standardization of recordings and automated measurements.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Usual care
Standard of care echocardiographic follow-up
Comprehensive echocardiographic follow-up
Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients
Simplified care
Simplified echocardiographic follow-up
Simplified echocardiographic follow-up
Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients
Interventions
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Comprehensive echocardiographic follow-up
Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients
Simplified echocardiographic follow-up
Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Espen Holte, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Olavs Hospital
Locations
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St. Olavs hospital
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Sabo S, Pettersen H, Boen GC, Jakobsen EO, Langoy PK, Nilsen HO, Pasdeloup D, Smistad E, Ostvik A, Lovstakken L, Stolen S, Grenne B, Dalen H, Holte E. Real-time guidance and automated measurements using deep learning to improve echocardiographic assessment of left ventricular size and function. Eur Heart J Imaging Methods Pract. 2025 Jul 21;3(2):qyaf094. doi: 10.1093/ehjimp/qyaf094. eCollection 2025 Jul.
Other Identifiers
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2019/1059
Identifier Type: -
Identifier Source: org_study_id
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