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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorColumbia University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA).

Known TTR amyloidosis.

Other reason that would make the subject inappropriate for entry into this study.

Trial design

Treatments tested in this trial

  • Tc99-PYP or Tc99-HDMP Scan

Treatment groups

1,663 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Columbia University

Lead sponsor

National Institute on Aging (NIA)

Collaborator