NCT06034405 Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
| NCT ID | NCT06034405 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Lumbar Spinal Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,663 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,663 participants in total. It began in 2023-09-19 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Clinically indicated spinal decompressive surgery within 20 years prior to enrollment. 2. Age ≥50 years at the time of the surgery. 3. 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: 1. Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA). 2. Known TTR amyloidosis. 3. Other reason that would make the subject inappropriate for entry into this study.
Contact & Investigator
Mathew S Maurer, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06034405 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Lumbar Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06034405 currently recruiting?
Yes, NCT06034405 is actively recruiting participants. Contact the research team at msm10@cumc.columbia.edu for enrollment information.
Where is the NCT06034405 trial being conducted?
This trial is being conducted at Beverly Hills, United States, Boston, United States, Boston, United States, Rochester, United States and 2 additional locations.
Who is sponsoring the NCT06034405 clinical trial?
NCT06034405 is sponsored by Columbia University. The principal investigator is Mathew S Maurer, MD at Columbia University. The trial plans to enroll 1,663 participants.