Identifying cardiac amyloidosis in older adults with lumbar spinal stenosis

Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis

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
• Enrollment: 1663 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Columbia University (Academic / other)
• Locations: 6 sites (Beverly Hills, California and 5 other locations)
• Trial ID: NCT06034405 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older who have had spinal decompressive surgery within the last 20 years.

Not a fit: Patients with confirmed primary or secondary amyloidosis or known TTR amyloidosis will not benefit from this study.

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 performed: 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.

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.

Where this trial is running

Beverly Hills, California and 5 other locations

• 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)
• Mayo Clinic — Rochester, Minnesota, United States (Active_not_recruiting)
• Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Mathew S Maurer, MD — Columbia University
• Study coordinator: Mathew S Maurer, MD

Conditions Lumbar Spinal Stenosis; Cardiac Amyloidosis; ATTR Amyloidosis Wild Type; ATTR Gene Mutation; ATTRV122I Amyloidosis; Cardiomyopathy, Hypertrophic