Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac Amyloidosis Screening at Trigger Finger Release (CAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03886155
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mazen Hanna MD, 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.

Condition or disease Intervention/treatment
Amyloidosis Trigger Finger Transthyretin Amyloidosis Primary Amyloidosis of Light Chain Type Procedure: Biopsy

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Amyloidosis Screening at Trigger Finger Release
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : October 1, 2020


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




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Trigger finger tenosynovium (may contain tenosynovial tissue and subcutaneous fat)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing trigger finger release surgery
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886155


Contacts
Layout table for location contacts
Contact: Mazen A Hanna, MD 2164443490 Hannam@ccf.org
Contact: Joseph P Donnelly, MD 3028932315 donnelj@ccf.org

Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Hanna Mazen, M. D.    216-444-3490    hannam@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Layout table for investigator information
Principal Investigator: Mazen A Hanna, MD The Cleveland Clinic

Publications:
Layout table for additonal information
Responsible Party: Mazen Hanna MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03886155     History of Changes
Other Study ID Numbers: 18-1511
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mazen Hanna MD, The Cleveland Clinic:
Surgery
Surgical release
Biopsy

Additional relevant MeSH terms:
Layout table for MeSH terms
Amyloidosis
Trigger Finger Disorder
Amyloid Neuropathies, Familial
Immunoglobulin Light-chain Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Nervous System Diseases
Amyloid Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Amyloidosis, Familial
Metabolism, Inborn Errors
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Paraproteinemias