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NCT06034405 · ClinicalTrials.gov registry record
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
A clinical trial of Lumbar Spinal Stenosis and Cardiac Amyloidosis, sponsored by Columbia University.
- Recruiting
- Registry status
- 1,663
- Enrollment target
- 6
- Study locations
NCT06034405 is a study of Lumbar Spinal Stenosis and Cardiac Amyloidosis that is actively recruiting participants, run by Columbia University. The registered enrollment target is 1,663 participants, above the 577-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (188% higher). The trial reports 6 study locations across 5 states.
The verdict
NCT06034405, a study of Lumbar Spinal Stenosis and Cardiac Amyloidosis, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- 1,663 participants
- Enrollment target
- 6
- Study locations
Study 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).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Tc99-PYP or Tc99-HDMP Scan
Study Locations (6)
Massachusetts
- Tufts Medical Center - Boston
- Boston Medical Center - Boston
California
- Cedars-Sinai Medical Center - Beverly Hills
Minnesota
- Mayo Clinic - Rochester
New York
- Columbia University Irving Medical Center - New York
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,663 participants |
| Start Date | 2023-09-19 |
| Est. Completion | 2028-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06034405
The ClinicalTrials.gov registry entry for NCT06034405 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,663 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 577-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (188% higher). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Lumbar Spinal Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Tc99-PYP or Tc99-HDMP Scan is the first listed.
NCT06034405 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06034405 about?
NCT06034405 is a clinical study titled "Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis". 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 lumb...
What is the current status of trial NCT06034405?
This trial is currently recruiting. The enrollment target is 1,663 participants. The study started on 2023-09-19. Estimated completion is 2028-05.
What conditions does trial NCT06034405 study?
This clinical trial studies the following conditions: Lumbar Spinal Stenosis, Cardiac Amyloidosis, Cardiomyopathy, Hypertrophic, ATTR Amyloidosis Wild Type, ATTR Gene Mutation.
What interventions are being tested in trial NCT06034405?
The interventions under investigation include: Tc99-PYP or Tc99-HDMP Scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06034405?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06034405 being conducted?
This trial has 6 study locations across California, Massachusetts, Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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