Recruiting

Observational Study

Sponsor:

Midwest Heart & Vascular Specialists

Code:

NCT06186167

Conditions

Amyloid

Cardiac Amyloidosis

Amyloidosis Cardiac

Systemic Amyloidosis

AL Amyloidosis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Chest Wall Fat Tissue Collection

Study Details

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

Study ID

NCT06186167

Start date

Jan 29, 2024

Status verified date

Dec, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis [ Time Frame: December 2023 to December 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed ]

Central Contacts and Locations

Central contacts

Vasvi Singh, MD

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

Elizabeth Fulks, MS

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

Locations

Midwest Heart & Vascular Specialists

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Elizabeth Fulks, MS

913-253-3000elizabeth.fulks@hcahealthcare.com

More Information

Sponsor

Midwest Heart & Vascular Specialists

Last update posted

Feb 20, 2024

Last verified

Dec, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Midwest Heart & Vascular Specialists on 2024-02-20.