Observational Study for Transthyretin Cardiac Amyloidosis in Lumbar Spinal Stenosis Patients
This observational study aims to find older adults with transthyretin cardiac amyloidosis (ATTR-CA) early, when treatments are most effective. Researchers are looking at spinal tissue from people who have had lumbar spinal stenosis (LSS) surgery to see if they have deposits of a protein called transthyretin (TTR). If TTR deposits are found, you might be invited for further evaluation for ATTR-CA, which includes tests like a Tc99-PYP or Tc99-HDMP Scan (a diagnostic imaging test), a genetic test, and heart evaluations. The study hopes to identify how many people with TTR deposits in their spine also have ATTR-CA. To join, you must be at least 50 years old, have had LSS surgery within the last 20 years, and be able to understand and sign the consent form. The current recruitment status is unclear.
- Study design
- This is a multicenter, prospective cohort observational study with a planned enrollment of 1663 participants. It is not randomized or blinded.
- What's involved
- If invited for further evaluation, you would undergo nuclear scintigraphy, a TTR genetic test, a clinical evaluation, electrocardiogram, echocardiogram, and complete quality of life questionnaires, likely all on a single day.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures the percentage of subjects with TTR amyloid deposits and risk for ATTR cardiac amyloidosis, measured at up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
At a glance
Conditions
Where it's being run
6 sites across 5 statesStudy leadership
- Mathew S Maurer, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
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What this trial measures
- Percent of subjects with previous LSS surgery who have evidence of TTR amyloid deposits in their spinal specimen and could be at risk for ATTR cardiac amyloidosisup to 3 years
To identify who can be at risk for ATTR Cardiac Amyloidosis. The investigator is going to collect spinal ligamentum flavum specimens and stain with congo red and those who result positive for ATTR amyloid in their spinal specimen will be counted