Cardiac Amyloidosis Screening at Trigger Finger Release (CAST)
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|ClinicalTrials.gov Identifier: NCT03886155|
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment|
|Amyloidosis Trigger Finger Transthyretin Amyloidosis Primary Amyloidosis of Light Chain Type||Procedure: Biopsy|
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 :||Observational|
|Estimated Enrollment :||100 participants|
|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|
Trigger Finger Biopsy
Biopsy of trigger finger tenosynovial tissue during trigger finger release surgery sent to pathology for amyloid-specific analysis
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.
- 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
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
|Contact: Mazen A Hanna, MD||2164443490||Hannam@ccf.org|
|Contact: Joseph P Donnelly, MDfirstname.lastname@example.org|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Hanna Mazen, M. D. 216-444-3490 email@example.com|
|Principal Investigator:||Mazen A Hanna, MD||The Cleveland Clinic|