Early Diagnosis of Age-Linked CArdiac TransThyRetin Amyloidosis by Selective Screening in Spinal Stenosis Surgery
Recruiting now
Conditions studied: Transthyretin Amyloid Cardiomyopathy
In brief
The goal of this observational study is to keep track of the cardiological follow-up of patients who have undergone back surgery because of symptomatic narrowing of the spinal canal and in whom microscopic examination of the tissue removed during this surgery showed a high amount of local deposits of small proteins. This finding may be an early sign of a condition in which other organs (especially the heart) may also be affected by these proteins, called amyloidosis. Patients who participate in this study, will be followed up for life. During the first routine consultation with the cardiologist, the physician-investigator will collect information, such as demographics (age, weight, height, gender), medical history, medication, symptoms and the results of prescribed examinations. These examinations include microscopic examination of tissue removed during the surgery, blood tests, electrocardiography, echocardiography and a bone scan. These examinations are clinically necessary and appropriate, and patients should undergo them even without participating in the study.
Key facts
- Study ID
- NCT06101108
- Run by
- Philippe Debonnaire
- People needed
- 400
- Starts
- 2024-06-24
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2024-08-07
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 60 years old
- Lumbar spinal canal stenosis, undergoing spinal surgery
- Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy
You may not qualify if…
- Prior diagnosis of cardiac amyloidosis
- Unwilling to provide informed consent
Where it is running
- AZ Sint-Jan Brugge AV — Bruges, Belgium (enrolling)
Full record on ClinicalTrials.gov
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