Spinal Stenosis Clinical Trial
— CASS-IIOfficial title:
Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.
Patients undergoing surgery for lumbar spinal stenosis will have biopsies of the ligamentum flavum sent to the department of pathology for histologic screening. If the ligament biopsy contains amyloid, patients will receive an echocardiogram, an ecg, biomarker testing, and a bone tracer scintigraphy diagnostic of cardiac amyloidosis.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | April 1, 2024 |
| Est. primary completion date | February 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility | Inclusion Criteria: - Scheduled for surgery for lumbar spinal stenosis - Age > 65 years - Informed written consent Exclusion Criteria: - Known amyloidosis - Myelomatosis - Monoclonal gammopathy of unknown significance, MGUS - Morbus Waldenstrøm |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Cardiology, Aarhus University Hospital | Aarhus N |
| Lead Sponsor | Collaborator |
|---|---|
| Steen Hvitfeldt Poulsen |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnosis of cardiac amyloidosis | DPD scintigraphy with a Perugini Grade 2 og higher. | 1 year |
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