Amyloidosis Incidence in High-Risk Cardiac Device Patients

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.

Study Overview

• Status: Recruiting
• Conditions: AL Amyloidosis; Amyloid; Cardiac Amyloidosis; Amyloidosis Cardiac; Systemic Amyloidosis; ATTR Amyloidosis Wild Type; Infiltrative Cardiomyopathy, Amyloid
• Intervention / Treatment: Procedure: Chest Wall Fat Tissue Collection

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Vasvi Singh, MD; Phone Number: (913) 253-3000; Email: vasvi.singh@hcahealthcare.com
• Study Contact Backup: Name: Elizabeth Fulks, MS; Phone Number: (913) 253-3000; Email: elizabeth.fulks@hcahealthcare.com

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Recruiting
      • Midwest Heart & Vascular Specialists
      • Contact: Elizabeth Fulks, MS; Phone Number: 913-253-3000; Email: elizabeth.fulks@hcahealthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Midwest Heart & Vascular Specialists
• Investigators: Principal Investigator: Vasvi Singh, MD, Midwest Heart & Vascular Specialists

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 16, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac Implantable Electronic Devices; Cardiac Devices; Chest Wall Fat Pad Biopsy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Paraproteinemias; Proteostasis Deficiencies; Neoplasms, Plasma Cell; Immunoglobulin Light-chain Amyloidosis; Amyloidosis; Cardiomyopathies
• Other Study ID Numbers: MWHV-AMYLO-BIOP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At present, the specifics of a data-sharing plan for individual participant data (IPD) from this study are under consideration. The study team intends to protect patient confidentiality and data integrity and will comply with all relevant regulations and guidelines for data sharing. Once a plan has been established, details about the nature of the data to be shared, the conditions for access, and the timing for data release will be provided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes