Actively Recruiting
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Led by Columbia University · Updated on 2025-11-12
1663
Participants Needed
6
Research Sites
240 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically indicated spinal decompressive surgery within 20 years prior to enrollment
- Age 50 years or older 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
You will not qualify if you...
- Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA)
- Known transthyretin amyloidosis
- Any other reason that would make the subject inappropriate for entry into this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
3
Boston Medical Center
Boston, Massachusetts, United States, 02359
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
5
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
6
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
M
Mathew S Maurer, MD
CONTACT
S
Samantha L Guadalupe, MHA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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