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Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome (CACTuS)

Primary Purpose

Amyloidosis Cardiac, Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DPD Scintigraphy
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyloidosis Cardiac

Eligibility Criteria

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

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

Sites / Locations

  • Department of Heart Disease

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Suspicion of cardiac amyloidosis

Arm Description

Patients who display signs of cardiac amyloidosis will be referred for further diagnosis.

Outcomes

Primary Outcome Measures

Prevalence of cardiac amyloidosis.
The prevalence of cardiac amyloidosis among patients previously operated for ipiopathic carpal tunnel syndrome.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2019
Last Updated
October 1, 2021
Sponsor
Aarhus University Hospital Skejby
Collaborators
Regional Hospital Holstebro
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1. Study Identification

Unique Protocol Identification Number
NCT03996382
Brief Title
Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome
Acronym
CACTuS
Official Title
Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Regional Hospital Holstebro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis Cardiac, Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suspicion of cardiac amyloidosis
Arm Type
Other
Arm Description
Patients who display signs of cardiac amyloidosis will be referred for further diagnosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
DPD Scintigraphy
Intervention Description
Confirms/Refutes diagnosis of cardiac amyloidosis.
Primary Outcome Measure Information:
Title
Prevalence of cardiac amyloidosis.
Description
The prevalence of cardiac amyloidosis among patients previously operated for ipiopathic carpal tunnel syndrome.
Time Frame
Through study completion, an average of 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Heart Disease
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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