About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Breast cancer and referral for follow-up to identify potential CTRCD
Disqualifiers
Not willing or able to consent
Trial design
Parallel
Treatments tested in this trial
Comprehensive echocardiographic follow-up
Diagnostic testComprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients
Simplified echocardiographic follow-up
Diagnostic testSimplified echocardiographic follow-up for identification of CRTCD in breast cancer patients
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)
Cancer treatment related cardiac dysfunction
Other outcomes
Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD)
Proportion of misclassified CTRCD
Risk classification
Risk classification for identification of CTRCD
Risk classification
Risk classification for identification of CTRCD
Test-retest variability, systolic left ventricular size and function
Test-retest variability of systolic left ventricular size and function
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian University of Science and Technology
Lead sponsor
St. Olavs Hospital
Collaborator