Prevalence of Cardiac Amyloidosis in Patients Undergoing... | NCT05701397

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

NCT05701397

Sponsor

Steen Hvitfeldt Poulsen

Status

Unknown status

Last Update Posted

Jan 27, 2023Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Cardiac Amyloidosis
Spinal Stenosis

Interventions

DPD scintigraphy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Feb 1, 2024Estimated

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Jan 16, 2023

First Submission Date that Met QC Criteria

Jan 26, 2023

First Posted Date

Jan 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2023

Last Update Posted Date

Jan 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Steen Hvitfeldt Poulsen, Professor, PhD, DMSci, Aarhus University Hospital SkejbySponsor-Investigator

Lead Sponsor

Steen Hvitfeldt PoulsenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
DPD scintigraphy	Diagnostic Test	Bone tracer scintigraphy, diagnostic for transthyretin cardiac amyloidsis	Study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bertil Ladefoged	Contact	40927245		berlad@rm.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Aarhus University Hospital	Recruiting	Aarhus N		8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D028227	Amyloid Neuropathies, Familial
D013130	Spinal Stenosis

Ancestor Terms

ID	Term
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases
D009422	Nervous System Diseases
D017772	Amyloid Neuropathies

Browse Leaves

Not provided

Browse Branches

Not provided