Screening for Systemic Amyloidosis Via the Ligamentum Flavum (ALF)
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|ClinicalTrials.gov Identifier: NCT03923920|
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment|
|Amyloid Amyloidosis Spinal Stenosis Transthyretin Amyloidosis Primary Amyloidosis of Light Chain Type||Procedure: Biopsy|
Similar to carpal tunnel syndrome, spinal stenosis is associated with systemic amyloidosis and presents earlier than cardiac amyloidosis symptoms - 21-45% of ATTR patients and case reports in AL patients. The investigators' 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. 70% of the amyloid-positive group had a history of spinal stenosis and 40% required surgical intervention. Surgical intervention for spinal stenosis could provide an opportunity to screen for amyloidosis through yellow ligament (ligamentum flavum) biopsy.
This study will look at the prevalence of amyloidosis in patients undergoing surgical intervention for non-congenital spinal stenosis and spondyloarthropathy. The investigators hypothesize that 10% of such patients will be positive for amyloidosis.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Screening for Systemic Amyloidosis Via the Ligamentum Flavum|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Spinal Stenosis Biopsy
Biopsy of ligamentum flavum tissue during spinal stenosis surgery sent to pathology for amyloid-specific analysis
During clinically-scheduled spinal stenosis surgery, ligamentum flavum tissue (which may contain surrounding tissue and subcutaneous fat) that is removed during the procedure will be sent to pathology to be analyzed with amyloid-specific staining.
- Incidence of amyloidosis in older patients undergoing spinal stenosis surgery [ Time Frame: Baseline to 30 days ]Incidence of amyloid deposits in removed ligamentum flavum tissue of older patients undergoing spinal stenosis surgery
Biospecimen Retention: Samples With 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): NCT03923920
|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: Mazen Hanna, M. D. 216-444-3490 email@example.com|
|Principal Investigator:||Mazen A Hanna, MD||The Cleveland Clinic|