AL Amyloidosis Clinical Trial
Official title:
Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Midwest Heart & Vascular Specialists | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
Midwest Heart & Vascular Specialists |
United States,
Takano R, Ueda N, Okada A, Matsumoto M, Ikeda Y, Hatakeyama K, Izumi C, Kusano K. Fat biopsy from a pocket of cardiac implantable electronic device: An alternative diagnostic option for cardiac amyloidosis. HeartRhythm Case Rep. 2022 May 18;8(8):554-557. doi: 10.1016/j.hrcr.2022.05.008. eCollection 2022 Aug. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis | The primary outcome measure is the histopathologic diagnosis of amyloidosis in chest wall fat tissue removed during cardiac device implantation | December 2023 to December 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed | |
Secondary | Development of a predictive screening model for cardiac amyloidosis | 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 | Retrospective analysis of patient data collected from December 2023 to December 2024 |
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