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

NCT06034405 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1663

Last updated 2025-11-12

No results posted yet for this study

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).

Conditions

  • Lumbar Spinal Stenosis
  • Cardiac Amyloidosis
  • ATTR Amyloidosis Wild Type
  • ATTR Gene Mutation
  • ATTRV122I Amyloidosis
  • Cardiomyopathy, Hypertrophic

Interventions

DIAGNOSTIC_TEST

Tc99-PYP or Tc99-HDMP Scan

Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in their spine by myocardial uptake of Tc99-PYP.

Sponsors & Collaborators

Principal Investigators

  • Mathew S Maurer, MD · Columbia University

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2026-05-31
Completion
2028-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06034405 on ClinicalTrials.gov