Cardiac Amyloidosis Screening at Trigger Finger Release

Completed

• Conditions: Amyloidosis; Primary Amyloidosis of Light Chain Type; Trigger Finger; Transthyretin Amyloidosis
• Interventions: Procedure: Biopsy

• Registration Number: NCT03886155
• Lead Sponsor: The Cleveland Clinic

Brief Summary

The investigators will prospectively evaluate for the presence of amyloid deposits in soft tissue samples obtained from patients undergoing trigger finger release surgery. Patients who have tissue that stains positive for amyloid will be referred to an amyloidosis specialist.

Detailed Description

A prospective study in 2001 showed that 23% (n = 47) of biopsies for idiopathic trigger finger were positive for Congo red staining but negative for ATTR and AL amyloid via immunohistochemistry. However, mass spectrometry is now the preferred method to type amyloid tissue. Trigger finger pathology involves the same flexor tenosynovium that passes through the carpal tunnel and has been biopsied to diagnose amyloidosis. Our recent study found that 10% of older patients undergoing carpal tunnel release surgery were positive for amyloidosis, with 20% of that group presenting with cardiac involvement. 60% of the amyloid-positive group had a history of trigger finger. Surgical intervention for trigger finger could provide an opportunity to screen for amyloidosis through tenosynovial biopsy.

This study will look at the prevalence of amyloidosis in patients undergoing surgical intervention for idiopathic trigger finger. The study hypothesis is at least 10% of such patients will be positive for amyloidosis.

Study Timeline

• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Study Start: 2019-05-01
• Primary Completion: 2020-07-02
• Status Verified: 2021-12
• Study Completion: 2021-12-02
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Age ≥50 years at the time of surgical biopsy.
• Undergoing surgical intervention for idiopathic trigger finger.
• Able to consent.

Exclusion Criteria

• Known history of amyloidosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trigger Finger Biopsy	Biopsy	Biopsy of trigger finger tenosynovial tissue during trigger finger release surgery sent to pathology for amyloid-specific analysis

Primary Outcome Measures

Name	Time	Method
Incidence of amyloidosis in older patients undergoing trigger finger release	Baseline to 30 days	Incidence of amyloid deposits in soft tissue removed from trigger finger tenosynovium in older patients undergoing trigger finger release surgery

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States