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

This trial accepts healthy volunteers

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 population

Previously procured surgical specimens from spinal surgery performed within 20 years prior to enrollment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tc99-PYP or Tc99-HDMP Scan

    Diagnostic test

    Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in their spine by myocardial uptake of Tc99-PYP.

Treatment groups

1,663 Participants
are divided into 2 treatment groups
Group A: ATTR Negative0 interventions
Group B: ATTR Positive1 intervention

Trial outcomes

Primary outcomes

1

Percent of subjects with previous LSS surgery who have evidence of TTR amyloid deposits in their spinal specimen and could be at risk for ATTR cardiac amyloidosis

To identify who can be at risk for ATTR Cardiac Amyloidosis. The investigator is going to collect spinal ligamentum flavum specimens and stain with congo red and those who result positive for ATTR amyloid in their spinal specimen will be counted

Time frame
up to 3 years

Secondary outcomes

1

Percent of subjects with ATTR-CA among those with localized TTR in their spinal tissue

To evaluate number of subjects with ATTR-CA among those with localized TTR in their spinal tissue. The investigator is going to perform standard of care (SOC) cardiac amyloidosis work up including PYP scan to confirm cardiac phenotype

Time frame
up to 6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute on Aging (NIA)

Collaborator