RecruitingNCT06034405

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


Sponsor

Columbia University

Enrollment

1,663 participants

Start Date

Sep 19, 2023

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Tc99-PYP or Tc99-HDMP Scan for people with attr amyloidosis wild type, attr gene mutation, and other related conditions. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTc99-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

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NCT06034405


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