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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996382
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Regional Hospital Holstebro
Information provided by (Responsible Party):
Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby

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.


Condition or disease Intervention/treatment Phase
Amyloidosis Cardiac Carpal Tunnel Syndrome Diagnostic Test: DPD Scintigraphy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : February 1, 2021


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996382


Contacts
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Contact: Steen Hvitfeldt Poulsen +4530922309 steepoul@rm.dk
Contact: Bertil Ladefoged +4540927245 201307379@post.au.dk

Locations
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Denmark
Department of Heart Disease Recruiting
Aarhus, Denmark, 8200
Contact: Steen Hvitfeldt Poulsen, Professor    +4530922309    steepoul@rm.dk   
Sponsors and Collaborators
Aarhus University Hospital Skejby
Regional Hospital Holstebro
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Responsible Party: Steen Hvitfeldt Poulsen, Professor, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT03996382    
Other Study ID Numbers: 1-10-72-330-18
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Amyloidosis
Syndrome
Disease
Pathologic Processes
Proteostasis Deficiencies
Metabolic Diseases
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries