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RECRUITING
NCT06034405

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

Sponsor: Columbia University

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1663

Start Date

2023-09-19

Completion Date

2028-05

Last Updated

2025-11-12

Healthy Volunteers

Yes

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.

Locations (6)

Cedars-Sinai Medical Center

Beverly Hills, California, United States

Tufts Medical Center

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States