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Cardiac Amyloidosis Screening at Trigger Finger Release

NCT ID: NCT03886155

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-12-02

Brief Summary

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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

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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

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Amyloidosis Trigger Finger Transthyretin Amyloidosis Primary Amyloidosis of Light Chain Type

Keywords

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Surgery Surgical release Biopsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trigger Finger Biopsy

Biopsy of trigger finger tenosynovial tissue during trigger finger release surgery sent to pathology for amyloid-specific analysis

Biopsy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mazen Hanna MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mazen A Hanna, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Cordiner-Lawrie S, Diaz J, Burge P, Athanasou NA. Localized amyloid deposition in trigger finger. J Hand Surg Br. 2001 Aug;26(4):380-3. doi: 10.1054/jhsb.2001.0571.

Reference Type BACKGROUND
PMID: 11469845 (View on PubMed)

Sperry BW, Reyes BA, Ikram A, Donnelly JP, Phelan D, Jaber WA, Shapiro D, Evans PJ, Maschke S, Kilpatrick SE, Tan CD, Rodriguez ER, Monteiro C, Tang WHW, Kelly JW, Seitz WH Jr, Hanna M. Tenosynovial and Cardiac Amyloidosis in Patients Undergoing Carpal Tunnel Release. J Am Coll Cardiol. 2018 Oct 23;72(17):2040-2050. doi: 10.1016/j.jacc.2018.07.092.

Reference Type BACKGROUND
PMID: 30336828 (View on PubMed)

Other Identifiers

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18-1511

Identifier Type: -

Identifier Source: org_study_id