AL Amyloidosis Clinical Trial

Amyloidosis Incidence in High-Risk Cardiac Device Patients

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.

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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.

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Eligibility Criteria

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 is for people with:

AL Amyloidosis

Estimated Enrollment:

100

Study ID:

NCT06186167

Recruitment Status:

Recruiting

Sponsor:

Midwest Heart & Vascular Specialists

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There is 1 Location for this study

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Midwest Heart & Vascular Specialists
Overland Park Kansas, 66211, United States More Info
Elizabeth Fulks, MS
Contact
913-253-3000
[email protected]

How clear is this clinincal trial information?

Study is for people with:

AL Amyloidosis

Estimated Enrollment:

100

Study ID:

NCT06186167

Recruitment Status:

Recruiting

Sponsor:


Midwest Heart & Vascular Specialists

How clear is this clinincal trial information?

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