Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310330
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-07
Brief Title:
TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
Technology Revising Ultrasound Solutions for Tomorrow - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRUST-ACE
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 eg ejection fraction EF and global longitudinal strain GLS can improve the precision of echocardiography in daily clinical practice
Secondly the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements eg 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None