Back to resultsPrevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis. (CASS-II)
Primary Purpose
Cardiac Amyloidosis, Spinal Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DPD scintigraphy
Sponsored by
About this trial
This is an interventional screening trial for Cardiac Amyloidosis
Eligibility Criteria
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
Sites / Locations
- Department of Cardiology, Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm 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.
Outcomes
Primary Outcome Measures
Diagnosis of cardiac amyloidosis
DPD scintigraphy with a Perugini Grade 2 og higher.
Secondary Outcome Measures
Full Information
NCT ID
NCT05701397
First Posted
January 16, 2023
Last Updated
January 26, 2023
Sponsor
Steen Hvitfeldt Poulsen
1. Study Identification
Unique Protocol Identification Number
NCT05701397
Brief Title
Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.
Acronym
CASS-II
Official Title
Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steen Hvitfeldt Poulsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis, Spinal Stenosis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
DPD scintigraphy
Intervention Description
Bone tracer scintigraphy, diagnostic for transthyretin cardiac amyloidsis
Primary Outcome Measure Information:
Title
Diagnosis of cardiac amyloidosis
Description
DPD scintigraphy with a Perugini Grade 2 og higher.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bertil Ladefoged
Phone
40927245
Email
berlad@rm.dk
Facility Information:
Facility Name
Department of Cardiology, Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertil Ladefoged
Phone
40927245
Email
berlad@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.
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