Study to Identify Transthyretin Cardiac Amyloidosis in Adults Over 50 With Previous Lumbar Spine Surgery Using Spinal Tissue Analysis and Heart Imaging

What this Trial Is About

Researchers are investigating older adults who previously had lumbar spinal stenosis LSS surgery to identify early signs of transthyretin cardiac amyloidosis ATTR-CA. The study aims to find evidence of transthyretin TTR amyloid deposits in spinal specimens and assess the risk of ATTR-CA in these individuals. This prospective cohort study also explores the prevalence of amyloid in spinal tissue and evaluates a new artificial intelligence method to detect amyloid using standard tissue staining techniques. Participants include those with past LSS surgery, whose spinal specimens will be analyzed for amyloid deposits. Those with localized TTR deposits will be invited for further evaluation involving nuclear scans using technetium pyrophosphate Tc99-PYP, genetic testing, clinical exams, ECG, and echocardiograms. The study involves cardiac phenotyping and genotyping to understand the presence of ATTR-CA, with some participants undergoing detailed cardiac imaging and testing. Most participants will complete evaluations and questionnaires in a single day at one of five medical centers. Researchers will collect medical records, analyze spinal tissue for amyloid, and perform heart imaging and tests to detect ATTR-CA. The main outcome measured is the percentage of participants with spinal TTR amyloid deposits who may be at risk for ATTR-CA within three years, along with the percentage who actually have ATTR-CA over six years. Quality of life assessments and safety monitoring are part of the study process.

Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis