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

• Sponsor: Aarhus University Hospital Skejby (Other)
• Overall Status: Completed
• CT.gov ID: NCT03996382
• Collaborator: Regional Hospital Holstebro (Other)
• Enrollment: 120
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.5
• Patients Per Site Per Month: 6.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Amyloidosis Cardiac; Carpal Tunnel Syndrome	Diagnostic Test: DPD Scintigraphy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 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: Jun 17, 2019
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Prevalence of cardiac amyloidosis. [Through study completion, an average of 2 years.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Heart Disease	Aarhus		Denmark	8200

Sponsors and Collaborators

• Aarhus University Hospital Skejby
• Regional Hospital Holstebro

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jun 24, 2019
• Last Update Posted: Oct 8, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carpal Tunnel Syndrome; Amyloidosis; Syndrome

Study Results

No Results Posted as of Oct 8, 2021