Clinical trial · Observational
Amyloidosis Incidence in High-Risk Cardiac Device Patients
Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AL Amyloidosis | AL Amyloidosis | ONTOLOGY_EXACT | 0.98 |
| Amyloid | — | UNRESOLVED | — |
| Amyloidosis Cardiac | — | UNRESOLVED | — |
| ATTR Amyloidosis Wild Type | — | UNRESOLVED | — |
| Cardiac Amyloidosis | — | UNRESOLVED | — |
| Infiltrative Cardiomyopathy, Amyloid | — | UNRESOLVED | — |
| Systemic Amyloidosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chest Wall Fat Tissue Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Procedure: Chest Wall Fat Tissue Collection
Primary outcomes (1)
- measure
- Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis
- timeFrame
- December 2023 to December 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed
- description
- The primary outcome measure is the histopathologic diagnosis of amyloidosis in chest wall fat tissue removed during cardiac device implantation
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDTakano 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. PMID 35996711