Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Recruiting now
Conditions studied: Lumbar Spinal Stenosis, Cardiac Amyloidosis, ATTR Amyloidosis Wild Type, ATTR Gene Mutation, ATTRV122I Amyloidosis, Cardiomyopathy, Hypertrophic
In brief
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).
Key facts
- Study ID
- NCT06034405
- Run by
- Columbia University
- People needed
- 1663
- Starts
- 2023-09-19
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- The presence of any of the following excludes eligibility for enrollment in this study:
- Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA).
- Known TTR amyloidosis.
- Other reason that would make the subject inappropriate for entry into this study.
Where it is running
- Cedars-Sinai Medical Center — Beverly Hills, California, United States (enrolling)
- Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
- Boston Medical Center — Boston, Massachusetts, United States (enrolling)
- Columbia University Irving Medical Center — New York, New York, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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