Identifying cardiac amyloidosis in older adults with lumbar spinal stenosis
Official title: Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Run by Columbia University · NCT06034405 · Data updated 2026-11-12
This study is trying to find out if older adults who have had surgery for lumbar spinal stenosis also have a heart condition called transthyretin cardiac amyloidosis by looking at their spinal tissue and using advanced technology.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 1663 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 6 sites (Beverly Hills, California and 5 other locations) |
| Status | Recruiting |
| Started | September 19, 2023 |
| Main results expected | May 2027 |
| Study ends | May 2028 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT06034405 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 50 and older who have had spinal decompressive surgery within the last 20 years.
✕Probably not a fit
Patients with confirmed primary or secondary amyloidosis or known TTR amyloidosis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify older adults who have undergone lumbar spinal stenosis surgery and may have transthyretin cardiac amyloidosis (ATTR-CA). By analyzing spinal specimens for amyloid deposits, the study seeks to evaluate the prevalence of ATTR-CA and explore the use of artificial intelligence in identifying amyloid histologically. Participants will undergo various diagnostic tests, including nuclear scintigraphy and echocardiograms, to assess the presence of clinical manifestations of ATTR-CA. The study will be conducted at multiple prestigious medical centers, with a focus on early identification of this condition to facilitate timely treatment.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and treatment of transthyretin cardiac amyloidosis in older adults, improving patient outcomes.
How similar studies have gone: While the approach of using spinal specimens to identify cardiac amyloidosis is innovative, similar studies have shown promise in identifying amyloid deposits in other contexts.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Cedars-Sinai Medical Center
Beverly Hills, California, United States Recruiting -
Tufts Medical Center
Boston, Massachusetts, United States Recruiting -
Boston Medical Center
Boston, Massachusetts, United States Recruiting -
Columbia University Irving Medical Center
New York, New York, United States Recruiting -
Cleveland Clinic
Cleveland, Ohio, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Active not recruiting
Study contacts
- Principal investigator: Mathew S Maurer, MD — Columbia University
- Study coordinator: Mathew S Maurer, MD
- Email: msm10@cumc.columbia.edu
- Phone: 212-932-4537
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.