Amyloidosis Incidence in High-Risk Cardiac Device Patients

Midwest Heart & Vascular Specialists

Status: Enrolling

Conditions: AL Amyloidosis; Amyloid; Infiltrative Cardiomyopathy, Amyloid; Systemic Amyloidosis; Cardiac Amyloidosis; ATTR Amyloidosis Wild Type; Amyloidosis Cardiac

Treatments: Procedure: Chest Wall Fat Tissue Collection

Study type: Observational

Funder types: Other

Identifiers

NCT06186167

MWHV-AMYLO-BIOP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

High-Risk Cardiac Device Recipients

Description:

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.

Treatment:

Procedure: Chest Wall Fat Tissue Collection