Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186167
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-12-16
Brief Title:
Amyloidosis Incidence in High-Risk Cardiac Device Patients
Sponsor:
Midwest Heart Vascular Specialists
Organization:
Midwest Heart Vascular Specialists
Study Overview
Official Title:
Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation
Status:
RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
This single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation By analyzing chest wall fat tissue which is usually discarded we aim to determine the diagnostic yield of such biopsies for amyloidosis and to develop a predictive screening model based on clinical lab and imaging data The study running from December 2023 to December 2024 expects to enroll 100 patients and may provide a new non-invasive diagnostic avenue for this condition
Detailed Description:
The study targets a key gap in cardiac amyloidosis diagnosis by systematically evaluating the histopathological incidence of the disease using chest wall fat pad biopsies-tissue that is typically discarded during the implantation of cardiac devices like pacemakers ICDs and CRT-DPs Standard surgical procedures are adhered to ensuring minimal additional risk to patients The collected tissue samples are analyzed by the HCA pathology laboratory to detect amyloid deposits thereby potentially identifying amyloidosis in a non-invasive manner In addition to the primary endpoint of histopathological diagnosis the study retrospectively aims to validate a predictive model that incorporates a wide range of data to streamline the identification of patients at high risk for cardiac amyloidosis Strict measures are in place to protect patient confidentiality and data security By potentially improving diagnostic efficiency this research could contribute to earlier detection and treatment strategies thus improving patient outcomes for those at high risk of this life-threatening condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None