Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.

Not Applicable

Recruiting

• Conditions: Spinal Stenosis; Cardiac Amyloidosis
• Interventions: Diagnostic Test: DPD scintigraphy

• Registration Number: NCT05701397
• Lead Sponsor: Steen Hvitfeldt Poulsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-26
• Last Update Submitted: 2023-01-26
• Study First Posted: 2023-01-27
• Last Update Posted: 2023-01-27
• Primary Completion: 2024-02-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	DPD scintigraphy	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.

Primary Outcome Measures

Name	Time	Method
Diagnosis of cardiac amyloidosis	1 year	DPD scintigraphy with a Perugini Grade 2 og higher.

Trial Locations

Locations (1)

Department of Cardiology, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark