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NCT Number: NCT06310330

TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Olavs hospital

Trondheim, 7491, Norway

Location status: Recruiting

Location contact

Rune Wiseth, MD, PhD

CONTACT

[email protected]

92247845 ext. 47

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not willing or able to consent

Treatment and study plan

Comprehensive echocardiographic follow-up

Diagnostic Test

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

Simplified echocardiographic follow-up

Diagnostic Test

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

Primary outcomes

  1. Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)

    Time frame: 15 months

    Cancer treatment related cardiac dysfunction

Other outcomes

  1. Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD)

    Time frame: 15 months

    Proportion of misclassified CTRCD

  2. Risk classification

    Time frame: 0 days

    Risk classification for identification of CTRCD

  3. Risk classification

    Time frame: 15 months

    Risk classification for identification of CTRCD

  4. Test-retest variability, systolic left ventricular size and function

    Time frame: 0 days

    Test-retest variability of systolic left ventricular size and function

  5. Test-retest variability, systolic left ventricular size and function

    Time frame: 15 months

    Test-retest variability systolic left ventricular size and function

  6. Test-retest variability, diastolic left ventricular size and function

    Time frame: 0 days

    Test-retest variability of diastolic left ventricular function

  7. Test-retest variability, diastolic left ventricular size and function

    Time frame: 15 months

    Test-retest variability of diastolic left ventricular size and function

  8. Test-retest variability, right ventricular size and function

    Time frame: 0 days

    Test-retest variability of right ventricular size and function

  9. Test-retest variability, right ventricular size and function

    Time frame: 15 months

    Test-retest variability of right ventricular size and function

  10. Time consumption

    Time frame: 0 days

    Time used for echocardiographic examination

  11. Time consumption

    Time frame: 15 days

    Time used for echocardiographic examination

Study contacts

Contact information is provided by the study sponsor or research team.

Espen Holte, MD. PhD

CONTACT

[email protected]

92243119 ext. 47

Havard Dalen, MD, PhD

CONTACT

[email protected]

95871716 ext. 47

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: TRUST-ACE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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