- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03886155
Cardiac Amyloidosis Screening at Trigger Finger Release (CAST)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of amyloidosis in older patients undergoing trigger finger release
Time Frame: Baseline to 30 days
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Incidence of amyloid deposits in soft tissue removed from trigger finger tenosynovium in older patients undergoing trigger finger release surgery
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Baseline to 30 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mazen A Hanna, MD, The Cleveland Clinic
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Musculoskeletal Diseases
- Muscular Diseases
- Paraproteinemias
- Proteostasis Deficiencies
- Neoplasms, Plasma Cell
- Tendinopathy
- Tendon Entrapment
- Immunoglobulin Light-chain Amyloidosis
- Amyloidosis
- Trigger Finger Disorder
Other Study ID Numbers
- 18-1511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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