Early detection of heart issues linked to spinal surgery in older patients
Early Diagnosis of Age-Linked CArdiac TransThyRetin Amyloidosis by Selective Screening in Spinal Stenosis Surgery: the Multi-centric ALCATTRASS-study.
This study is trying to see if checking for certain heart issues during spinal surgery can help older patients find early signs of a heart condition called ATTR-CM.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | AZ Sint-Jan AV Academic / other |
| Locations | 1 site (Bruges) |
| Trial ID | NCT06101108 on ClinicalTrials.gov |
What this trial studies
This observational study aims to track the cardiological follow-up of patients over 60 years old who undergo spinal surgery for symptomatic lumbar spinal stenosis. During surgery, tissue samples will be examined for amyloid deposits, which may indicate early signs of transthyretin amyloid cardiomyopathy (ATTR-CM). Patients will be monitored for life, with data collected on demographics, medical history, and results from various cardiac examinations. The study seeks to validate a screening strategy for early detection of ATTR-CM in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older undergoing spinal surgery for lumbar spinal canal stenosis.
Not a fit: Patients with a prior diagnosis of cardiac amyloidosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and treatment of ATTR-CM, improving patient outcomes.
How similar studies have performed: While the approach is novel, the study aims to validate a screening strategy that has not been widely implemented yet.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 60 years old * Lumbar spinal canal stenosis, undergoing spinal surgery * Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy Exclusion Criteria: * Prior diagnosis of cardiac amyloidosis * Unwilling to provide informed consent
Where this trial is running
Bruges
- AZ Sint-Jan Brugge AV — Bruges, Belgium (Recruiting)
Study contacts
- Principal investigator: Philippe Debonnaire, MD, PhD — AZ Sint-Jan Brugge AV
- Study coordinator: Emma Christiaen
- Email: emma.christiaen@azsintjan.be
- Phone: 0032 50 45 32 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.