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

RECRUITINGSponsored by Columbia University
Actively Recruiting
SponsorColumbia University
Started2023-09-19
Est. completion2026-05
Eligibility
Age50 Years+
Healthy vol.Accepted
Locations6 sites

Summary

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

Age: 50 Years+Healthy volunteers accepted
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.

Conditions7

ATTR Amyloidosis Wild TypeATTR Gene MutationATTRV122I AmyloidosisCardiac AmyloidosisCardiomyopathy, HypertrophicHeart DiseaseLumbar Spinal Stenosis

Locations6 sites

Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Shruti Shantharam310-248-8365shruti.shantharam@csmns.org
Tufts Medical Center
Boston, Massachusetts, 02111
Ayan Patel, MD617-636-4184ayan.patel@tuftsmedicine.org
Boston Medical Center
Boston, Massachusetts, 02359
Frederick Ruberg, MD617-638-8771frederick.ruberg@bmc.org
Mayo Clinic
Rochester, Minnesota, 55905
Columbia University Irving Medical Center
New York, New York, 10032
Jeffeny DeLosSantos, MHA212-932-4537jd3456@cumc.columbia.edu

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