Clinical trial NCT06186167: Amyloidosis Incidence in High-Risk Cardiac Device Patients
Official title: Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyloid
Cardiac Amyloidosis
Amyloidosis Cardiac
Systemic Amyloidosis
AL Amyloidosis
Infiltrative Cardiomyopathy, Amyloid
ATTR Amyloidosis Wild Type
Keywords: Cardiac Devices
Chest Wall Fat Pad Biopsy
Cardiac Implantable Electronic Devices
Lead sponsor: Midwest Heart & Vascular Specialists
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High-risk patients undergoing cardiac device implantation who meet the study's inclusion criteria.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis
timeFrame: December 2023 to December 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed
Secondary outcomes:
measure: Development of a predictive screening model for cardiac amyloidosis
timeFrame: Retrospective analysis of patient data collected from December 2023 to December 2024
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Midwest Heart & Vascular Specialists
state: Kansas
Study officials:
affiliation: Midwest Heart & Vascular Specialists
name: Vasvi Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.