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

January 26, 2023 updated by: Steen Hvitfeldt Poulsen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bertil Ladefoged
  • Phone Number: 40927245
  • Email: berlad@rm.dk

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Department of Cardiology, Aarhus University Hospital
        • Contact:
          • Bertil Ladefoged
          • Phone Number: 40927245
          • Email: berlad@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
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.
Diagnostic test: DPD scintigraphy
Bone tracer scintigraphy, diagnostic for transthyretin cardiac amyloidsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of cardiac amyloidosis
Time Frame: 1 year
DPD scintigraphy with a Perugini Grade 2 og higher.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steen Hvitfeldt Poulsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-116-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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