NCT05701397

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

January 16, 2023

Last Update Submit

January 26, 2023

Conditions

Cardiac AmyloidosisSpinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of cardiac amyloidosis

    DPD scintigraphy with a Perugini Grade 2 og higher.

    1 year

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

DPD scintigraphyDIAGNOSTIC_TEST

Bone tracer scintigraphy, diagnostic for transthyretin cardiac amyloidsis

Study group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Scheduled for surgery for lumbar spinal stenosis
  • Age \> 65 years
  • Informed written consent

You may not qualify if:

  • Known amyloidosis
  • Myelomatosis
  • Monoclonal gammopathy of unknown significance, MGUS
  • Morbus Waldenstrøm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, FamilialSpinal Stenosis

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis DeficienciesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Bertil Ladefoged

CONTACT

40927245berlad@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, PhD, DMSci

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 27, 2023

Study Start

January 1, 2023

Primary Completion

February 1, 2024

Study Completion

April 1, 2024

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)