Amyloidosis Incidence in High-Risk Cardiac Device Patients

NCT06186167 | Unknown DMC FDA Device

• 1 other identifier: MWHV-AMYLO-BIOP-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cardiac Devices; Chest Wall Fat Pad Biopsy; Cardiac Implantable Electronic Devices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Development of a predictive screening model for cardiac amyloidosis

  Retrospective analysis of patient data collected from December 2023 to December 2024

Study Arms (1)

High-Risk Cardiac Device Recipients

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.

Procedure: Chest Wall Fat Tissue Collection

Interventions

Chest Wall Fat Tissue Collection PROCEDURE

As part of routine cardiac device implantation, chest wall fat tissue is collected for histopathological analysis. This tissue, which is typically discarded, will be used to identify amyloid deposits in high-risk cardiac patients. No additional surgical intervention is performed beyond the standard procedure for device implantation.

High-Risk Cardiac Device Recipients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High-risk patients undergoing cardiac device implantation who meet the study's inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwest Heart & Vascular Specialists: lead

Study Sites (1)

Midwest Heart & Vascular Specialists

Overland Park, Kansas, 66211, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35996711 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The biospecimens consist of chest wall fat tissue samples collected during cardiac device implantation procedures. This adipose tissue, typically excised to create space for the device, is preserved for histopathological analysis to detect amyloid deposits. The analysis of these samples is crucial for diagnosing cardiac amyloidosis in patients at high risk. The tissue will be handled and analyzed by the HCA pathology laboratory, following standard procedures to ensure the integrity of the samples and the accuracy of the diagnostic results.

MeSH Terms

Conditions

Alzheimer Disease; Amyloid Neuropathies, Familial; Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Heredodegenerative Disorders, Nervous System; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Study Officials

• Vasvi Singh, MD

  Midwest Heart & Vascular Specialists

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasvi Singh, MD

CONTACT

(913) 253-3000; vasvi.singh@hcahealthcare.com

Elizabeth Fulks, MS

CONTACT

(913) 253-3000; elizabeth.fulks@hcahealthcare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: December 29, 2023
• Study Start: January 29, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2023-12

Locations

US (1)