Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06186167
Study type Observational
Source Midwest Heart & Vascular Specialists
Contact Vasvi Singh, MD
Phone (913) 253-3000
Email vasvi.singh@hcahealthcare.com
Status Recruiting
Phase
Start date January 29, 2024
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04459169 - Cardiac Amyloidosis : Diagnostic Using Red Flag Signals
Recruiting NCT03029026 - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Recruiting NCT06034405 - Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Recruiting NCT04915235 - Prevalence and Prognosis of Cardiac Amiloidosis in Turkey
Recruiting NCT02966522 - Thalidomide/Dexamethasone Treatment And PET Evaluation In Organ Involvemenet of Cardiac Amyloidosis Phase 2
Terminated NCT03333551 - Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy Phase 4
Recruiting NCT04105634 - Molecular Imaging of the Underlying Mechanism of Cardiotoxicity in Patients With Light Chain Amyloidosis Using PET/CT Early Phase 1
Recruiting NCT05139797 - Artificial Intelligence Guided Echocardiographic Screening of Rare Diseases (EchoNet-Screening)
Not yet recruiting NCT05593679 - A Multi-center Cardiac PYP Scan Registry in Taiwan.
Not yet recruiting NCT04146415 - Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera N/A
Not yet recruiting NCT06427304 - Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure
Recruiting NCT06469372 - Cardiac Amyloidosis Discovery Trial N/A
Recruiting NCT04856267 - Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders
Completed NCT03119558 - PET/MRI Evaluation of Cardiac Amyloid Early Phase 1
Recruiting NCT02798705 - Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis
Not yet recruiting NCT04387344 - Morpho-functional Cardiac Modifications in Treated Mutated Transthyretin Cardiac Amyloidosis
Recruiting NCT06129656 - Cardiac Amyloidosis Registry of University Hospital Leipzig
Terminated NCT01683825 - Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography Phase 4
Withdrawn NCT04363294 - Targeted Testing for ATTR Among Aortic Stenosis Patients-Pilot N/A
Not yet recruiting NCT04661800 - Study of Olfactory Disorders in Patients With Cardiac Amyloidosis N/A