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Checking spine tissue from older adults for a heart protein buildup

Checks spinal tissue from adults 50 and older for signs of heart amyloidosis.

Plain-language title generated from the registry record
Registry title: Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis

Key facts

Where
Beverly Hills, Boston, Cleveland, New York, and Rochester, United StatesSee the 6 sites

Where in United States

  • Cedars-Sinai Medical CenterBeverly Hills, United StatesTaking people
  • Boston Medical CenterBoston, United StatesTaking people
  • Tufts Medical CenterBoston, United StatesTaking people
  • Cleveland ClinicCleveland, United StatesTaking people
  • Columbia University Irving Medical CenterNew York, United StatesTaking people
  • Mayo ClinicRochester, United StatesNo longer taking part

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Trial details

Who runs it
Columbia University
Trial code
NCT06034405
Record updated
4 June 2026
Original description
Primary objective:Read full original descriptionShow less

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

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).

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT06034405