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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Tc99-PYP or Tc99-HDMP Scan
Diagnostic testDifference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in their spine by myocardial uptake of Tc99-PYP.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
Sponsors and contacts
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Columbia University
Lead sponsor
National Institute on Aging (NIA)
Collaborator