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

October 1, 2021 updated by: Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Department of Heart Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Suspicion of cardiac amyloidosis
Patients who display signs of cardiac amyloidosis will be referred for further diagnosis.
Diagnostic test: DPD Scintigraphy
Confirms/Refutes diagnosis of cardiac amyloidosis.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Collaborators

Regional Hospital Holstebro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-330-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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