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TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

Technology Revising Ultrasound Solutions for Tomorrow - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06310330
Acronym
TRUST-ACE
Enrollment
250
Registered
2024-03-15
Start date
2024-03-08
Completion date
2026-12-31
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm Malignant Primary

Keywords

echocardiography, breast cancer, artificial intelligence, cardiotoxicity

Brief summary

TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD). 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.

Detailed description

Cancer treatment related cardiac dysfunction (CTRCD) is a well-known complication to cancer treatment with implication both with respect to treatment and prognosis of the cancer as well as heart. 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.

Interventions

DIAGNOSTIC_TESTComprehensive echocardiographic follow-up

Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients

DIAGNOSTIC_TESTSimplified echocardiographic follow-up

Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER
St. Olavs Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

No masking

Intervention model description

Randomization 1:1 to two different modes of follow-up

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Breast cancer and referral for follow-up to identify potential CTRCD

Exclusion criteria

* Not willing or able to consent

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)15 monthsCancer treatment related cardiac dysfunction

Countries

Norway

Contacts

CONTACTEspen Holte, MD. PhD
espen.holte@stolav.no92243119
CONTACTHavard Dalen, MD, PhD
havard.dalen@ntnu.no95871716
PRINCIPAL_INVESTIGATOREspen Holte, MD, PhD

St. Olavs Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026