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

NCT ID: NCT05701397

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-04-01

Brief Summary

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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

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Conditions

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Cardiac Amyloidosis Spinal Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DPD scintigraphy

Intervention Type DIAGNOSTIC_TEST

Bone tracer scintigraphy, diagnostic for transthyretin cardiac amyloidsis

Interventions

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DPD scintigraphy

Bone tracer scintigraphy, diagnostic for transthyretin cardiac amyloidsis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Steen Hvitfeldt Poulsen

OTHER

Sponsor Role lead

Responsible Party

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Steen Hvitfeldt Poulsen

Professor, PhD, DMSci

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Cardiology, Aarhus University Hospital

Aarhus N, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Bertil Ladefoged

Role: CONTACT

Facility Contacts

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Bertil Ladefoged

Role: primary

Other Identifiers

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1-10-72-116-22

Identifier Type: -

Identifier Source: org_study_id

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