Amyloidosis Incidence in High-Risk Cardiac Device Patients

Cardiac Amyloidosis Clinical Trial

Official title:

Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186167
• Other study ID #: MWHV-AMYLO-BIOP-001
• Status: Recruiting
• Start date: January 29, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Midwest Heart & Vascular Specialists
• Contact: Vasvi Singh, MD
• Phone: (913) 253-3000
• Email: vasvi.singh[@]hcahealthcare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• AL Amyloidosis
• Amyloid
• Amyloidosis
• Amyloidosis Cardiac
• Cardiac Amyloidosis
• Cardiomyopathies
• Immunoglobulin Light-chain Amyloidosis
• Systemic Amyloidosis

Intervention

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.

Locations

Country	Name	City	State
United States	Midwest Heart & Vascular Specialists	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Midwest Heart & Vascular Specialists

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

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