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Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study (CACTuS 2)

Primary Purpose

Transthyretin Amyloidosis, Transthyretin Cardiac Amyloidosis, Wild-Type Transthyretin-Related (ATTR)Amyloidosis

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Tenosynovial biopsy
Sponsored by
Steen Hvitfeldt Poulsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transthyretin Amyloidosis

Eligibility Criteria

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

Inclusion Criteria:

  • Males above 65 years of age, females above 75 years of age.
  • Scheduled idiopathic carpal tunnel release surgery.
  • Informed written consent.

Exclusion Criteria:

  • Operation by other indication, e.g.
  • Fracture
  • Ganglion
  • Known amyloidosis

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tenosynovial Biopsy

Arm Description

Outcomes

Primary Outcome Measures

Diagnosis of wild-type transthyretin cardiac amyloidosis
Diagnosis of wild-type cardiac amyloidosis will be determined by TC99-DPD scintigraphy, endomyocardial biopsy, or both.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2020
Last Updated
November 21, 2022
Sponsor
Steen Hvitfeldt Poulsen
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1. Study Identification

Unique Protocol Identification Number
NCT04276220
Brief Title
Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study
Acronym
CACTuS 2
Official Title
Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steen Hvitfeldt Poulsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination. If the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test. Myocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transthyretin Amyloidosis, Transthyretin Cardiac Amyloidosis, Wild-Type Transthyretin-Related (ATTR)Amyloidosis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tenosynovial Biopsy
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Tenosynovial biopsy
Intervention Description
Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.
Primary Outcome Measure Information:
Title
Diagnosis of wild-type transthyretin cardiac amyloidosis
Description
Diagnosis of wild-type cardiac amyloidosis will be determined by TC99-DPD scintigraphy, endomyocardial biopsy, or both.
Time Frame
Through study completion, 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males above 65 years of age, females above 75 years of age. Scheduled idiopathic carpal tunnel release surgery. Informed written consent. Exclusion Criteria: Operation by other indication, e.g. Fracture Ganglion Known amyloidosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bertil Ladefoged
Phone
+45 40 92 72 45
Email
berlad@rm.dk
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Jylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steen Poulsen, DMSci
Email
steepoul@rm.dk
First Name & Middle Initial & Last Name & Degree
Bertil Ladefoged, MD
Email
berlad@rm.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study

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