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Completed

NCT Number: NCT03886155

Cardiac Amyloidosis Screening at Trigger Finger Release

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.

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Key information

Conditions

Amyloidosis Amyloidosis, Hereditary, Transthyretin-Related Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nutritional and Metabolic Diseases Paraproteinemias Primary Amyloidosis of Light Chain Type Proteostasis Deficiencies Tendinopathy Tendon Entrapment Transthyretin Amyloidosis Trigger Finger Trigger Finger Disorder

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biopsy

Procedure

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.

Primary outcomes

  1. Incidence of amyloidosis in older patients undergoing trigger finger release

    Time frame: Baseline to 30 days

    Incidence of amyloid deposits in soft tissue removed from trigger finger tenosynovium in older patients undergoing trigger finger release surgery

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: CAST

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 22, 2019
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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