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

Who can join

Ages 50 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

1. Clinically indicated spinal decompressive surgery within 20 years prior to enrollment.
2. Age ≥50 years at the time of the surgery.
3. Able to understand and sign the informed consent document after the nature of the study has been fully explained.

Exclusion Criteria:

The presence of any of the following excludes eligibility for enrollment in this study:

1. Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA).
2. Known TTR amyloidosis.
3. Other reason that would make the subject inappropriate for entry into this study.

About the study

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).

What is being tested

• Tc99-PYP or Tc99-HDMP Scan (diagnostic test)

Sponsor: Columbia University · Participants: 1,663 · Started: Sep 19, 2023

Contact the study team

• Mathew S Maurer, MD · Phone: 212-932-4537
• Samantha L Guadalupe, MHA · Phone: 212-932-4537

Official record on ClinicalTrials.gov — NCT06034405

Locations in the U.S.

Conditions

• Spinal Stenosis
• Familial Amyloid Neuropathies
• Hypertrophic Cardiomyopathy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.