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NCT05701410 Clinical Trial

Prevalence of Cardiac Amyloidosis Among Patients With a History of Lumbar Spinal Stenosis.

Spinal Stenosis Clinical Trial

— CASS-I  

Official title:
Prevalence of Cardiac Amyloidosis Among Patients With a History of Lumbar Spinal Stenosis.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05701410
Other study ID # 1-10-72-117-22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date April 1, 2024

Study information
Verified date January 2023
Source Aarhus University Hospital Skejby
Contact Bertil Ladefoged, MD
Phone +45 40927245
Email berlad@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study investigates the prevalence of cardiac amyloidosis among patients with a history of lumbar spinal stenosis within the last ten years in the region of central Denmark.

Recruitment information / eligibility
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 60 Years and older
Eligibility Inclusion Criteria: - History of lumbar spinal stenosis. - Age > 60 years at the time of spinal stenosis surgery. - Written informed consent. Exclusion Criteria: - Known amyloidosis - Myelomatosis - Monoclonal gammopathy of unknown origin, MGUS - Morbus Waldenstrøm

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DPD scintigraphy
Bone tracer scintigraphy, diagnostic for transthyretin amyloidosis.

Locations
Country Name City State
Denmark Department of Cardiology, Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
Steen Hvitfeldt Poulsen

Country where clinical trial is conducted

Denmark, 

Outcome
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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