ClinicalTrials.gov record NCT06034405

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age50 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study examines previously removed lumbar spine tissue for transthyretin (TTR) amyloid and evaluates whether those findings are linked to ATTR cardiac amyloidosis. Stored spinal specimens will be screened (Congo Red, mass spectrometry, and exploratory AI analysis on H&E). People whose spinal tissue shows TTR deposits are invited for a one-day cardiac evaluation including a Tc99-PYP (nuclear) scan, heart imaging (echocardiogram), ECG, TTR genetic testing, and questionnaires.

What it is studying. The study is testing whether TTR amyloid found in lumbar spinal stenosis specimens is associated with cardiac ATTR disease. It also measures how common amyloid and TTR deposits are in spine specimens and evaluates a new artificial-intelligence approach to detect amyloid histologically.

What the researchers hope to learn. Scientifically, the study aims to identify people at risk for transthyretin cardiac amyloidosis by finding TTR in spinal tissue; estimate the prevalence of spinal amyloid and of TTR deposits; evaluate the prevalence of cardiac ATTR among those with spinal TTR; and test an AI method for detecting amyloid on standard H&E stains. It also compares ATTR-CA prevalence between subjects with TTR versus indeterminate spinal amyloid using myocardial uptake on Tc99-PYP scans.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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:

  • 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.
  • To evaluate for ATTR-CA among those with localized TTR in the spinal tissue.

The study will also explore the following:

  • The prevalence of amyloid in lumbar spinal stenosis specimens by Congo Red staining.
  • The prevalence of TTR deposits among subjects with amyloid as determined by mass spectrometry.
  • Evaluation of a novel artificial intelligence technique for that can identify amyloid histologically with standard H\&E staining.
  • 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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • Tc99-PYP or Tc99-HDMP Scan

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Researchers will examine previously removed spinal surgery tissue at the Mayo Clinic core lab for amyloid using Congo Red stain and, if present, mass spectrometry to identify transthyretin (TTR). People whose spinal tissue shows TTR may be invited to a single on-site visit for a clinical evaluation, electrocardiogram (ECG), echocardiogram, a TTR genetic test, quality-of-life questionnaires, and a nuclear imaging scan (Tc99‑PYP or Tc99‑HDMP), with SPECT/SPECT‑CT imaging as needed. Most participants are expected to complete the study procedures and questionnaires in one day. For the study, participants with myocardial tracer uptake at a Perugini score of 2 or 3 and no evidence of monoclonal proteins will be classified as having ATTR cardiac amyloidosis.

How the study is structured. This is a multicenter, prospective observational cohort. Investigators will examine up to 1,663 previously procured lumbar spinal specimens for amyloid using Congo Red staining at a central pathology core, with mass spectrometry to identify the precursor protein. People whose specimens show localized TTR deposits will be invited to a site visit for cardiac phenotyping: Tc99-PYP or Tc99‑HDMP nuclear scintigraphy (with SPECT or SPECT/CT confirmation), echocardiogram, electrocardiogram, TTR genetic testing, a clinical evaluation, and quality-of-life questionnaires. Most participants are expected to complete the on-site procedures and questionnaires in a single day. The registry notes investigators expect to recruit a subset (about 163) for cardiac phenotyping from the pool with spinal amyloid.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Lumbar Spinal Stenosis; Cardiac Amyloidosis; ATTR Amyloidosis Wild Type; ATTR Gene Mutation; ATTRV122I Amyloidosis; Cardiomyopathy, Hypertrophic. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 19, 2023
Primary completion
May 2027 (estimated)
Study completion
May 2028 (estimated)
Target enrollment
1663 participants (estimated)
Last updated on registry
Jun 4, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Columbia University
Principal investigator
Mathew S. Maurer, MD, Arnold and Arlene Goldstein Professor of Cardiology (in Medicine, Dept of Medicine Cardiology)
Columbia University
Collaborators
  • National Institute on Aging (NIA)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (6)

Terms used on this page · explanations by MedicalUpdates.ai

Primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
prospective cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
electrocardiogram
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
echocardiogram
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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