TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

Breast Neoplasm Malignant Primary Clinical Trial

— TRUST-ACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310330
• Other study ID #: 2019/1059
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Norwegian University of Science and Technology
• Contact: Espen Holte, MD. PhD
• Phone: 92243119
• Email: espen.holte[@]stolav.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not willing or able to consent

Related Conditions & MeSH terms

• Breast Neoplasm Malignant Primary
• Breast Neoplasms
• Cardiotoxicity
• Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Norway	St. Olavs hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD)	Proportion of misclassified CTRCD	15 months
Other	Risk classification	Risk classification for identification of CTRCD	0 days
Other	Risk classification	Risk classification for identification of CTRCD	15 months
Other	Test-retest variability, systolic left ventricular size and function	Test-retest variability of systolic left ventricular size and function	0 days
Other	Test-retest variability, systolic left ventricular size and function	Test-retest variability systolic left ventricular size and function	15 months
Other	Test-retest variability, diastolic left ventricular size and function	Test-retest variability of diastolic left ventricular function	0 days
Other	Test-retest variability, diastolic left ventricular size and function	Test-retest variability of diastolic left ventricular size and function	15 months
Other	Test-retest variability, right ventricular size and function	Test-retest variability of right ventricular size and function	0 days
Other	Test-retest variability, right ventricular size and function	Test-retest variability of right ventricular size and function	15 months
Other	Time consumption	Time used for echocardiographic examination	0 days
Other	Time consumption	Time used for echocardiographic examination	15 days
Primary	Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)	Cancer treatment related cardiac dysfunction	15 months