About this trial
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.
Eligibility criteria
Qualifiers
≥ 60 years old
Lumbar spinal canal stenosis, undergoing spinal surgery
Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy
Disqualifiers
Prior diagnosis of cardiac amyloidosis
Unwilling to provide informed consent
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Philippe Debonnaire
Lead sponsor
AZ Sint-Jan AV
Sponsor institution