NCT03886155

Cardiac Amyloidosis Screening at Trigger Finger Release

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 107 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyloidosis
• Trigger Finger
• Transthyretin Amyloidosis
• Primary Amyloidosis of Light Chain Type

Interventions

Type	Name	Description
PROCEDURE	Biopsy	During clinically-scheduled trigger finger release surgery, soft tissue will be removed from the trigger finger tenosynovium (which may include synovial sheath and subcutaneous fat tissue) and send to pathology to be analyzed with amyloid-specific staining.

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-07-02
• Completion: 2021-12-02
• First posted: 2019-03-22
• Last updated: 2021-12-22

Locations

1 site across 1 country: United States