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

Sponsor

Steen Hvitfeldt Poulsen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04276220

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Transthyretin Amyloidosis Transthyretin Cardiac Amyloidosis Wild-Type Transthyretin-Related (ATTR)Amyloidosis	Diagnostic Test: Tenosynovial biopsy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 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 Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Tenosynovial Biopsy	Diagnostic Test: Tenosynovial biopsy Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.

Arm

Intervention/Treatment

Other: Tenosynovial Biopsy

Diagnostic Test: Tenosynovial biopsy

Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.

Outcome Measures

Primary Outcome Measures

Diagnosis of wild-type transthyretin cardiac amyloidosis [Through study completion, 2 years.]
Diagnosis of wild-type cardiac amyloidosis will be determined by TC99-DPD scintigraphy, endomyocardial biopsy, or both.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus	Jylland	Denmark	8200

Sponsors and Collaborators

Steen Hvitfeldt Poulsen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steen Hvitfeldt Poulsen, Professor, DMSc, Aarhus University Hospital Skejby

ClinicalTrials.gov Identifier:

NCT04276220

Other Study ID Numbers:

1-10-72-178-19

First Posted:

Feb 19, 2020

Last Update Posted:

Oct 8, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Amyloidosis

Study Results

No Results Posted as of Oct 8, 2021