Amyloidosis Incidence in High-Risk Cardiac Device Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-29

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Atrial Amyloid May Influence Outcomes in Patients Undergoing Surgical Aortic Valve Replacement

NCT07105501

Aortic Stenosis Amyloid

COMPLETED

Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis

NCT04636684

Amyloidosis

RECRUITING NA

Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR

NCT06015997

ATTR Amyloidosis Wild Type Severe Aortic Stenosis Aortic Valve Stenosis +1 more

NOT_YET_RECRUITING

Impact of Amyloidosis on TAVI Patients

NCT03984877

Valve Stenoses, Aortic Amyloidosis Cardiac

UNKNOWN

Characteristics of Patients With Amyloidosis & Heart Failure Being Evaluated for a Heart Transplant

NCT00456040

Cardiomyopathy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Chest Wall Fat Tissue Collection

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No