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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

• Clinically indicated spinal decompressive surgery within 20 years prior to enrollment.

• Age ≥50 years at the time of the surgery.

• Able to understand and sign the informed consent document after the nature of the study has been fully explained.

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Beverly Hills
Massachusetts
Boston Medical Center
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Minnesota
Mayo Clinic
ACTIVE_NOT_RECRUITING
Rochester
New York
Columbia University Irving Medical Center
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Mathew S Maurer, MD
msm10@cumc.columbia.edu
212-932-4537
Backup
Samantha L Guadalupe, MHA
slg2172@cumc.columbia.edu
212-932-4537
Time Frame
Start Date: 2023-09-19
Estimated Completion Date: 2028-05
Participants
Target number of participants: 1663
Treatments
ATTR Negative
Participants who have undergone previous lumbar spinal, and/or carpel tunnel surgery will provide medical record data and spinal specimen for analysis of presence of ATTR amyloid.
ATTR Positive
Participants who have undergone previous lumbar spinal, and/or carpel tunnel surgery will provide medical record data, spinal specimen, prospective data from cardiac workup with confirmed ATTR amyloid in spinal specimen then undergo cardiac workup for cardiac phenotyping/genotyping.
Sponsors
Leads: Columbia University
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov