Amyloidosis Incidence in High-Risk Cardiac Device Patients

Recruiting

• Conditions: Infiltrative Cardiomyopathy, Amyloid; ATTR Amyloidosis Wild Type; Cardiac Amyloidosis; Systemic Amyloidosis; AL Amyloidosis; Amyloid; Amyloidosis Cardiac
• Interventions: Procedure: Chest Wall Fat Tissue Collection

• Registration Number: NCT06186167
• Lead Sponsor: Midwest Heart & Vascular Specialists

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-D/Ps. 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 Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-16
• Study First Submitted QC: 2023-12-16
• Study First Posted: 2023-12-29
• Study Start: 2024-01-29
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who are 40 years of age or older
• Patients who are able and willing to provide informed consent
• Patients who are scheduled for CIED implantation within the study period and with clinical lab and imaging features suggestive of cardiac amyloidosis

Exclusion Criteria

• Individuals below the age of 40.
• Persons who are unable to consent or who do not consent to participate.
• Patients who have already been diagnosed with cardiac amyloidosis prior to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-Risk Cardiac Device Recipients	Chest Wall Fat Tissue Collection	Participants in this cohort are individuals undergoing clinically indicated cardiac device implantation, such as pacemakers, ICDs, ILRs, or CRT-D/Ps. During the standard implantation procedure, chest wall fat tissue typically excised to create space for the device is collected for histopathological analysis to identify amyloid deposits. This study involves no additional intervention beyond the routine clinical care received by the patients.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis	December 2023 to December 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed	The primary outcome measure is the histopathologic diagnosis of amyloidosis in chest wall fat tissue removed during cardiac device implantation

Secondary Outcome Measures

Name	Time	Method
Development of a predictive screening model for cardiac amyloidosis	Retrospective analysis of patient data collected from December 2023 to December 2024	Retrospective development and validation of a predictive model using pre-procedural clinical, lab, and imaging data to identify patients at high risk for cardiac amyloidosis

Trial Locations

Locations (1)

Midwest Heart & Vascular Specialists; 🇺🇸 Overland Park, Kansas, United States