Clinical Trials Logo

Clinical Trial Summary

Primary objective: To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective. The specific aims of this epidemiologic investigation include: 1. To identify subjects with previous lumbar spinal stenosis (LSS) Surgery who have evidence of transthyretin (TTR) amyloid deposits in spinal specimens and could be at risk for ATTR cardiac amyloidosis. 2. To evaluate for ATTR-CA among those with localized TTR in the spinal tissue. The study will also explore the following: 1. The prevalence of amyloid in lumbar spinal stenosis specimens by Congo Red staining. 2. The prevalence of TTR deposits among subjects with amyloid as determined by mass spectrometry. 3. Evaluation of a novel artificial intelligence technique for that can identify amyloid histologically with standard H&E staining. 4. Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in subject's spine by myocardial uptake of technetium pyrophosphate scan (Tc99-PYP).


Clinical Trial Description

This is a multicenter, prospective cohort study aimed at facilitating identification of individuals with ATTR-CA. Investigators will identify subjects with previous LSS surgery who have evidence of TTR amyloid deposits in spinal specimens. Subjects with localized TTR in spinal tissue will be invited to an on-site visit and be evaluated for the presence of clinical manifestations of ATTR cardiac amyloidosis (ATTR-CA). Subjects will undergo nuclear scintigraphy, TTR genetic test, a clinical evaluation, electrocardiogram, and echocardiogram. Quality of life questionnaires will also be administered. Subjects who have myocardial retention of the imaging radiotracer with a Perugini score equal to 2 (uptake equal to bone) or 3 (uptake greater than bone) and confirmation by SPECT or SPECT/CT that the uptake is myocardial in nature and have no evidence of monoclonal proteins will be diagnosed with ATTR-CA. This study is to be conducted at five study sites: Boston Medical Center, Cedars Sinai Medical Center, Cleveland Clinic, Columbia University Irving Medical Center, and Tufts University Medical Center. The Mayo Clinic will serve a Pathology research core to analyze spine specimens. Most of the subjects are expected to complete all the study procedures and questionnaires on a single day. Up to 1663 patients will be consented in this study to have spinal specimens examined for the presence of amyloid by Congo Red at the Mayo Clinic core lab. From the pool of subjects with amyloid detected (which anticipate will be 33% or at least 544), the investigators expect to recruit 163 participants to undergo cardiac phenotyping (Tc99m and cardiac evaluation). Among the 163 participants who undergo cardiac phenotyping, 98 will have TTR as the precursor protein identified by mass spectrometry and 65 will have an indeterminant precursor protein by mass spectrometry. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06034405
Study type Observational
Source Columbia University
Contact Mathew S Maurer, MD
Phone 212-932-4537
Email msm10@cumc.columbia.edu
Status Recruiting
Phase
Start date September 19, 2023
Completion date May 2028

See also
  Status Clinical Trial Phase
Recruiting NCT04795284 - Biomechanical Parameters of Gait in Patients With Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
Recruiting NCT04066296 - Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine Phase 2
Active, not recruiting NCT05114135 - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study) N/A
Recruiting NCT06075862 - Balance Amongst Patients With Lumbar Spinal Stenosis
Recruiting NCT06057428 - Activity Levels Amongst Patients With Lumbar Spinal Stenosis
Recruiting NCT05527145 - Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial N/A
Recruiting NCT01902979 - The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial N/A
Completed NCT00749073 - The Vertos MILD™ Preliminary Patient Evaluation Study N/A
Completed NCT00527527 - Chiropractic Dosage for Lumbar Stenosis Phase 2
Completed NCT00405691 - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis Phase 3
Completed NCT03194607 - Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
Completed NCT06079580 - Patients With Lumbar Spinal Stenosis With Balance Disorder
Recruiting NCT05523388 - Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Completed NCT04563793 - Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Suspended NCT03381677 - Pedicle Osteotomy for Stenosis Trial N/A
Completed NCT02258672 - Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis N/A
Completed NCT02260401 - Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis N/A
Completed NCT01994512 - Swedish Spinal Stenosis Study N/A
Completed NCT00401518 - A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis N/A