Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Columbia University
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).
Description
This is a multicenter, prospective cohort study aimed at facilitating identification of individuals with ATTR-CA. Investigators will identify subjects with previous LSS surgery who have evidence of TTR amyloid deposits in spinal specimens. Subjects with localized TTR in spinal tissue will be invited to an on-site visit and be evaluated for the presence of clinical manifestations of ATTR cardiac amyloidosis (ATTR-CA). Subjects will undergo nuclear scintigraphy, TTR genetic test, a clinical evaluation, electrocardiogram, and echocardiogram. Quality of life questionnaires will also be administer…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- Yes
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.
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 CenterBeverly Hills, California
- Tufts Medical CenterBoston, Massachusetts
- Boston Medical CenterBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- Columbia University Irving Medical CenterNew York, New York
- Cleveland ClinicCleveland, Ohio