Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-02 @ 6:43 AM
Study NCT ID:
NCT05452850
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2022-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis
Sponsor:
Istanbul University - Cerrahpasa
Organization:
Study Overview
Official Title:
Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis: Prognostic Significance
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
The purpose of this study to assess the longitudinal changes in left and right ventricular global strain after chemotherapeutic strategies in cardiac light chain amyloidosis.
Detailed Description:
Light chain amyloidosis is a disease characterized by localized or systemic accumulation of amyloid fibrils in tissues caused by abnormal folding of light chain immunoglobulins and affecting organ functions. In the treatment, chemotherapeutic agents are used that prevent the clonal proliferation of plasma cells in the bone marrow. Although the hematological response is standardized in evaluating the treatment response, there is no adequately effective method for assessing cardiac response. Despite the use of various scores, imaging-based systems continue to be developed to increase the sensitivity of these methods.
After being informed about the study, it is planned to recruit and follow-up AL-Amyloidosis patients with cardiac involvement who are currently receiving/planned chemotherapy followed by hematology or who are planned for bone marrow transplantation within 1 year after obtaining written consent from the patients.
After being informed about the study, it is planned to recruit and follow-up AL-Amyloidosis patients with cardiac involvement who are currently receiving/planned chemotherapy followed by hematology or who are planned for bone marrow transplantation within 1 year after obtaining written consent from the patients.
Study Oversight
Has Oversight DMC:
True
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?: