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Prevalence of Cardiac Amyloidosis Among Patients With a History of Lumbar Spinal Stenosis. (CASS-I)

Primary Purpose

Cardiac Amyloidosis, Spinal Stenosis

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

DPD scintigraphy

About this trial

This is an interventional screening trial for Cardiac Amyloidosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Cardiology, Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Patients with a history of lumbar spinal stenosis.

Outcomes

Primary Outcome Measures

Diagnosis of cardiac amyloidosis

DPD scintigraphy with a Perugini Grade 2 og higher.

Secondary Outcome Measures

Full Information

NCT ID

NCT05701410

First Posted

January 16, 2023

Last Updated

January 26, 2023

Sponsor

Steen Hvitfeldt Poulsen

1. Study Identification

Unique Protocol Identification Number

NCT05701410

Brief Title

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

Acronym

CASS-I

Official Title

Prevalence of Cardiac Amyloidosis Among Patients With a History of 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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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 with a history of lumbar spinal stenosis.

Intervention Type

Diagnostic Test

Intervention Name(s)

DPD scintigraphy

Intervention Description

Bone tracer scintigraphy, diagnostic for transthyretin amyloidosis.

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

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bertil Ladefoged, MD

Phone

+45 40927245

berlad@rm.dk

Facility Information:

Facility Name

Department of Cardiology, Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bertil Ladefoged

Phone

40927245

berlad@rm.dk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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