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NCT06034405Recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
1663 (estimated)
First submitted
17 Aug 2023
Start date
19 Sept 2023
Primary completion date
May 2027
Lead sponsor
Columbia University
NCT number
NCT06034405

What you commit to

  • Study type: Observational
  • Planned participants: 1663
  • From 19 Sept 2023 to the primary completion date, May 2027
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cedars-Sinai Medical Center
Coordinator of this site? Confirm its status
Beverly HillsUnited StatesRecruiting
Boston Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Tufts Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Columbia University Irving Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.