Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511388
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas A Two and Three-dimensional Echocardiographic Speckle Tracking Imaging Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas A Two and Three-Dimensional Echocardiographic Speckle Tracking Imaging Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to identify markers that will allow researchers to identify in advance patients with sarcomas who are at highest risk for developing heart failure related to chemotherapy
Detailed Description:
PRIMARY OBJECTIVES
I To detect acute and subacute changes in myocardial function by two-dimensional 2D-Speckle Tracking Echocardiography STE derived strain and strain rate in sarcoma patients undergoing chemotherapeutic treatment
Ia To compare 2D-STE and three-dimensional 3D-STE derived strain and strain-rate Ib To compare 2D-STE and 2D- and 3D-left ventricle ejection fraction LVEF Ic If feasible to compare 2D-STE and cardiac biomarkers serum cardiac troponin T and N-terminal fragment of brain natriuretic peptide NT-proBNP
II To predict chemotherapy-induced cardiotoxicity by using 2D-STE andor other significant parameters for early detection of cardiac dysfunction
OUTLINE This is an observational study
Patients receive anthracycline once a day or split between 2-3 days per standard of care SOC Patients undergo 2D-STE throughout the study and have their medical records reviewed on study
I To detect acute and subacute changes in myocardial function by two-dimensional 2D-Speckle Tracking Echocardiography STE derived strain and strain rate in sarcoma patients undergoing chemotherapeutic treatment
Ia To compare 2D-STE and three-dimensional 3D-STE derived strain and strain-rate Ib To compare 2D-STE and 2D- and 3D-left ventricle ejection fraction LVEF Ic If feasible to compare 2D-STE and cardiac biomarkers serum cardiac troponin T and N-terminal fragment of brain natriuretic peptide NT-proBNP
II To predict chemotherapy-induced cardiotoxicity by using 2D-STE andor other significant parameters for early detection of cardiac dysfunction
OUTLINE This is an observational study
Patients receive anthracycline once a day or split between 2-3 days per standard of care SOC Patients undergo 2D-STE throughout the study and have their medical records reviewed on study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None