Actively Recruiting

Age: 50Years +
All Genders
Healthy Volunteers
ID06034405

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

Led by Columbia University · Updated on 2026-06-04

1663

Participants Needed

6

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating older adults who previously had lumbar spinal stenosis (LSS) surgery to identify early signs of transthyretin cardiac amyloidosis (ATTR-CA). The study aims to find evidence of transthyretin (TTR) amyloid deposits in spinal specimens and assess the risk of ATTR-CA in these individuals. This prospective cohort study also explores the prevalence of amyloid in spinal tissue and evaluates a new artificial intelligence method to detect amyloid using standard tissue staining techniques. Participants include those with past LSS surgery, whose spinal specimens will be analyzed for amyloid deposits. Those with localized TTR deposits will be invited for further evaluation involving nuclear scans using technetium pyrophosphate (Tc99-PYP), genetic testing, clinical exams, ECG, and echocardiograms. The study involves cardiac phenotyping and genotyping to understand the presence of ATTR-CA, with some participants undergoing detailed cardiac imaging and testing. Most participants will complete evaluations and questionnaires in a single day at one of five medical centers. Researchers will collect medical records, analyze spinal tissue for amyloid, and perform heart imaging and tests to detect ATTR-CA. The main outcome measured is the percentage of participants with spinal TTR amyloid deposits who may be at risk for ATTR-CA within three years, along with the percentage who actually have ATTR-CA over six years. Quality of life assessments and safety monitoring are part of the study process.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically indicated spinal decompressive surgery within 20 years prior to enrollment
  • Age 50 years or older 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
Not Eligible

You will not qualify if you...

  • Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA)
  • Known transthyretin (TTR) amyloidosis
  • Other reasons that would make the subject inappropriate for entry into this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for consent and initial eligibility assessment

Diagnostic Evaluation

Duration - Single day

Participants with previous lumbar spine or carpal tunnel surgery provide spinal specimens for analysis of amyloid deposits and undergo cardiac evaluation to identify transthyretin cardiac amyloidosis (ATTR-CA).

1 visit (in-person) including nuclear scintigraphy, TTR genetic testing, clinical evaluation, electrocardiogram, echocardiogram, and questionnaires

Long-term Monitoring

Duration - Up to 6 years

Participants are observed for the presence and progression of ATTR-CA based on cardiac phenotyping and clinical assessments.

Visits as clinically indicated; schedule may vary depending on participant status

Trial Site Locations

Total: 6 locations

1

Cedars-Sinai Medical Center

Beverly Hills, California, United States, 90211

Actively Recruiting

2

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

3

Boston Medical Center

Boston, Massachusetts, United States, 02359

Actively Recruiting

4

Mayo Clinic

Rochester, Minnesota, United States, 55905

Active, Not Recruiting

5

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

6

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

M

Mathew S Maurer, MD

S

Samantha L Guadalupe, MHA

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Evolution of a Geriatric Syndrome: Pathophysiology and Treatment of Heart Failure with Preserved Ejection Fraction.

Bharathi Upadhya, Barbara Pisani, Dalane W Kitzman

https://pubmed.ncbi.nlm.nih.gov/29124734

Prevalence of Transthyretin Amyloid Cardiomyopathy in Heart Failure With Preserved Ejection Fraction.

Omar F AbouEzzeddine, Daniel R Davies, Christopher G Scott...

https://pubmed.ncbi.nlm.nih.gov/34431962

Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction.

Esther González-López, Maria Gallego-Delgado, Gonzalo Guzzo-Merello...

https://pubmed.ncbi.nlm.nih.gov/26224076

Unveiling transthyretin cardiac amyloidosis and its predictors among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

Adam Castaño, David L Narotsky, Nadira Hamid...

https://pubmed.ncbi.nlm.nih.gov/29019612