RecruitingNCT06034405

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


Sponsor

Columbia University

Enrollment

1,663 participants

Start Date

Sep 19, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 50 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria4

  • The presence of any of the following excludes eligibility for enrollment in this study:
  • Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA).
  • Known TTR amyloidosis.
  • Other reason that would make the subject inappropriate for entry into this study.

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Interventions

DIAGNOSTIC_TESTTc99-PYP or Tc99-HDMP Scan

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


Locations(6)

Cedars-Sinai Medical Center

Beverly Hills, California, United States

Tufts Medical Center

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

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NCT06034405


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