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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
Kansas
Midwest Heart & Vascular Specialists
RECRUITING
Overland Park
Contact Information
Primary
Vasvi Singh, MD
vasvi.singh@hcahealthcare.com
(913) 253-3000
Backup
Elizabeth Fulks, MS
elizabeth.fulks@hcahealthcare.com
(913) 253-3000
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Leads: Midwest Heart & Vascular Specialists

This content was sourced from clinicaltrials.gov