Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis. (CASS-II)

Steen Hvitfeldt Poulsen

Status: Enrolling

Conditions: Cardiac Amyloidosis; Spinal Stenosis

Treatments: Diagnostic Test: DPD scintigraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT05701397

1-10-72-116-22

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Study group

Experimental group

Description:

Patients undergoing surgery for lumbar spinal stenosis. Patients will have a biopsy taken from the ligamentum flavum and test for the presence of amyloid. Patients with amyloid in the ligamentum flavum will be referred for a DPD scintigraphy.

Treatment:

Diagnostic Test: DPD scintigraphy