Prevalence of Wild Type Transthyretin Cardiac Amyloidosis... | NCT03996382

Studies
Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome

NCT03996382

Sponsor

Aarhus University Hospital Skejby

Status

Completed

Last Update Posted

Oct 8, 2021Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Amyloidosis Cardiac
Carpal Tunnel Syndrome

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2019Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Jun 17, 2019

First Submission Date that Met QC Criteria

Jun 21, 2019

First Posted Date

Jun 24, 2019Actual

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

Oct 1, 2021

Last Update Posted Date

Oct 8, 2021Actual

Name	Class
Regional Hospital Holstebro	OTHER

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

Wild-type transthyretin cardiac amyloidosis is an underdiagnosed depository disease in which fibril monomers of misfolded amyloid protein accumulates in various tissues, including the heart, and cause tissue dysfunction.

Before onset of cardiac symptoms, many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.

This study investigates patients previously operated for idiopathic carpal tunnel syndrome to determine if they display signs and symptoms 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

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suspicion of cardiac amyloidosis	Other	Patients who display signs of cardiac amyloidosis will be referred for further diagnosis.	Diagnostic Test: DPD Scintigraphy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DPD Scintigraphy	Diagnostic Test	Confirms/Refutes diagnosis of cardiac amyloidosis.	Suspicion of cardiac amyloidosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of cardiac amyloidosis.	The prevalence of cardiac amyloidosis among patients previously operated for ipiopathic carpal tunnel syndrome.	Through study completion, an average of 2 years.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients above sixty years of age previously operated for idiopathic carpal tunnel syndrome within the Region of Central Denmark (Region Midtjylland) the last five years.
Informed written and verbal consent

Exclusion Criteria:

Operation by different indication such as
- Fracture
- Ganglion
- Tumors
- Osteophytes
- Rheumatoid Arthritis
- Persistent medial artery
- Metabolic causes
Alcoholism
Hyperthyroidism
Myxedema
- Hereditary Cardiac Amyloidosis
- Known WT ATTR
- AL Amyloidosis
- Myelomatosis
- MGUS and Morbus Waldenström

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Heart Disease		Aarhus		8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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
D002349	Carpal Tunnel Syndrome

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