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

Conditions

• ATTR Amyloidosis Wild Type
• ATTR Gene Mutation
• ATTRV122I Amyloidosis
• Cardiac Amyloidosis
• Cardiomyopathy, Hypertrophic
• Lumbar Spinal Stenosis

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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).

Key Dates

Start date

Sep 19, 2023

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

May 31, 2028

Study Design

Enrollment

1,663 participants (estimated)

Arms

• Arm: ATTR Negative
  Participants who have undergone previous lumbar spinal, and/or carpel tunnel surgery will provide medical record data and spinal specimen for analysis of presence of ATTR amyloid.
• Arm: ATTR Positive
  Participants who have undergone previous lumbar spinal, and/or carpel tunnel surgery will provide medical record data, spinal specimen, prospective data from cardiac workup with confirmed ATTR amyloid in spinal specimen then undergo cardiac workup for cardiac phenotyping/genotyping.

Primary Outcome Measure

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 [ Time Frame: up to 3 years ]

Central Contacts

• Mathew S Maurer, MD
  212-932-4537
  [email protected]
• Samantha L Guadalupe, MHA
  212-932-4537
  [email protected]

Locations (6)

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