NCT06034405Recruiting
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1663 (estimated)
- First submitted
- 17 Aug 2023
- Start date
- 19 Sept 2023
- Primary completion date
- May 2027
- Lead sponsor
- Columbia University
- Diseases
- Amyloidosis, Hypertrophic cardiomyopathy
- NCT number
- NCT06034405
What you commit to
- Study type: Observational
- Planned participants: 1663
- From 19 Sept 2023 to the primary completion date, May 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Beverly Hills | United States | Recruiting |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.