St. Olavs hospital
Trondheim, 7491, Norway
Location status: Recruiting
NCT Number: NCT06310330
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Trondheim, 7491, Norway
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients
Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients
Time frame: 15 months
Cancer treatment related cardiac dysfunction
Time frame: 15 months
Proportion of misclassified CTRCD
Time frame: 0 days
Risk classification for identification of CTRCD
Time frame: 15 months
Risk classification for identification of CTRCD
Time frame: 0 days
Test-retest variability of systolic left ventricular size and function
Time frame: 15 months
Test-retest variability systolic left ventricular size and function
Time frame: 0 days
Test-retest variability of diastolic left ventricular function
Time frame: 15 months
Test-retest variability of diastolic left ventricular size and function
Time frame: 0 days
Test-retest variability of right ventricular size and function
Time frame: 15 months
Test-retest variability of right ventricular size and function
Time frame: 0 days
Time used for echocardiographic examination
Time frame: 15 days
Time used for echocardiographic examination
Contact information is provided by the study sponsor or research team.
Norwegian University of Science and Technology
Other
Technology Revising Ultrasound Solutions for Tomorrow - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
Acronym: TRUST-ACE
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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