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NCT Number: NCT06034405

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

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).

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Key information

Conditions

Lumbar Spinal Stenosis ATTR Amyloidosis Wild Type ATTR Gene Mutation ATTRV122I Amyloidosis Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Bone Diseases Cardiac Amyloidosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Heredodegenerative Disorders, Nervous System Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies Spinal Diseases Spinal Stenosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center, Beverly Hills, California, United States

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About this study

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 administered. Subjects who have myocardial retention of the imaging radiotracer with a Perugini score equal to 2 (uptake equal to bone) or 3 (uptake greater than bone) and confirmation by SPECT or SPECT/CT that the uptake is myocardial in nature and have no evidence of monoclonal proteins will be diagnosed with ATTR-CA.

This study is to be conducted at five study sites: Boston Medical Center, Cedars Sinai Medical Center, Cleveland Clinic, Columbia University Irving Medical Center, and Tufts University Medical Center. The Mayo Clinic will serve a Pathology research core to analyze spine specimens.

Most of the subjects are expected to complete all the study procedures and questionnaires on a single day.

Up to 1663 patients will be consented in this study to have spinal specimens examined for the presence of amyloid by Congo Red at the Mayo Clinic core lab. From the pool of subjects with amyloid detected (which anticipate will be 33% or at least 544), the investigators expect to recruit 163 participants to undergo cardiac phenotyping (Tc99m and cardiac evaluation). Among the 163 participants who undergo cardiac phenotyping, 98 will have TTR as the precursor protein identified by mass spectrometry and 65 will have an indeterminant precursor protein by mass spectrometry.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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

  1. Percent of subjects with ATTR-CA among those with localized TTR in their spinal tissue

    Time frame: up to 6 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mathew S Maurer, MD

CONTACT

[email protected]

212-932-4537

Samantha L Guadalupe, MHA

CONTACT

[email protected]

212-932-4537

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 13, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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