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

Columbia University · with National Institute on Aging (NIA) · NCT06034405

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
1663
US sites recruiting
5
Study start
September 19, 2023
Record last updated
June 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Tc99-PYP or Tc99-HDMP Scan

Conditions: Lumbar Spinal Stenosis; Cardiac Amyloidosis; ATTR Amyloidosis Wild Type; ATTR Gene Mutation; ATTRV122I Amyloidosis; Cardiomyopathy, Hypertrophic

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Cedars-Sinai Medical Center

    Beverly Hills, CA 90211

    Site contact: Shruti Shantharam · 310-248-8365 · shruti.shantharam@csmns.org

  • Tufts Medical Center

    Boston, MA 02111

    Site contact: Ayan Patel, MD · 617-636-4184 · ayan.patel@tuftsmedicine.org

  • Boston Medical Center

    Boston, MA 02359

    Site contact: Frederick Ruberg, MD · 617-638-8771 · frederick.ruberg@bmc.org

  • Columbia University Irving Medical Center

    New York, NY 10032

    Site contact: Jeffeny DeLosSantos, MHA · 212-932-4537 · jd3456@cumc.columbia.edu

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Mazen Hanna, MD · 216-444-3490 · hannam@ccf.org

Study contacts (from the official record)

  • Mathew S Maurer, MD · 212-932-4537 · msm10@cumc.columbia.edu
  • Samantha L Guadalupe, MHA · 212-932-4537 · slg2172@cumc.columbia.edu
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