Midwest Heart & Vascular Specialists
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.
Amyloid
Cardiac Amyloidosis
Amyloidosis Cardiac
Systemic Amyloidosis
AL Amyloidosis
Infiltrative Cardiomyopathy, Amyloid
ATTR Amyloidosis Wild Type
Chest Wall Fat Tissue Collection
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.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 100 participants |
| Official Title : | Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation |
| Actual Study Start Date : | 2024-01-29 |
| Estimated Primary Completion Date : | 2024-12-31 |
| Estimated Study Completion Date : | 2024-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 40 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Midwest Heart & Vascular Specialists
Overland Park, Kansas, United States, 66211