Observational Study for Transthyretin Cardiac Amyloidosis in Lumbar Spinal Stenosis Patients

This observational study aims to find older adults with transthyretin cardiac amyloidosis (ATTR-CA) early, when treatments are most effective. Researchers are looking at spinal tissue from people who have had lumbar spinal stenosis (LSS) surgery to see if they have deposits of a protein called transthyretin (TTR). If TTR deposits are found, you might be invited for further evaluation for ATTR-CA, which includes tests like a Tc99-PYP or Tc99-HDMP Scan (a diagnostic imaging test), a genetic test, and heart evaluations. The study hopes to identify how many people with TTR deposits in their spine also have ATTR-CA. To join, you must be at least 50 years old, have had LSS surgery within the last 20 years, and be able to understand and sign the consent form. The current recruitment status is unclear.

Study design
This is a multicenter, prospective cohort observational study with a planned enrollment of 1663 participants. It is not randomized or blinded.
What's involved
If invited for further evaluation, you would undergo nuclear scintigraphy, a TTR genetic test, a clinical evaluation, electrocardiogram, echocardiogram, and complete quality of life questionnaires, likely all on a single day.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures the percentage of subjects with TTR amyloid deposits and risk for ATTR cardiac amyloidosis, measured at up to 3 years.

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NCT06034405

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

Recruiting
Not specifiedAges 50+Observational
Columbia University
~1,663 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Tc99-PYP or Tc99-HDMP Scan

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of subjects with previous LSS surgery who have evidence of TTR amyloid deposits in their spinal specimen and could be at risk for ATTR cardiac amyloidosis
Measured over up to 3 years
Lumbar Spinal Stenosis
Cardiac Amyloidosis
ATTR Amyloidosis Wild Type
ATTR Gene Mutation
ATTRV122I Amyloidosis
Cardiomyopathy, Hypertrophic
6 sites across 5 states
Massachusetts2
California1
Minnesota1
New York1
Ohio1
  • Mathew S Maurer, MD · PRINCIPAL_INVESTIGATOR · Columbia University

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  • Percent of subjects with previous LSS surgery who have evidence of TTR amyloid deposits in their spinal specimen and could be at risk for ATTR cardiac amyloidosisup to 3 years

    To identify who can be at risk for ATTR Cardiac Amyloidosis. The investigator is going to collect spinal ligamentum flavum specimens and stain with congo red and those who result positive for ATTR amyloid in their spinal specimen will be counted