Disturbed flow in radial-cephalic arteriovenous fistulae for haemodialysis: low and oscillating shear stress locates the sites of stenosis.
Bogdan Ene-Iordache, Andrea Remuzzi
https://pubmed.ncbi.nlm.nih.gov/21771751/Actively Recruiting
Led by Mario Negri Institute for Pharmacological Research · Updated on 2025-09-04
15
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying the connection between blood flow conditions and the sounds produced by arteriovenous fistulas AVFs in patients with end-stage renal disease ESRD who require vascular access for hemodialysis. This study aims to better understand how blood flow affects AVF function and to explore if analyzing these sounds can help predict AVF health. The trial focuses on non-drug methods to improve AVF monitoring and reduce failures. Participants will have an AVF surgically created and then undergo several diagnostic tests including non-contrast enhanced MRI scans and advanced 3D ultrasound examinations to create detailed blood flow models. The study includes a series of visits starting with screening and enrollment, surgery day, and follow-up visits at 0-14 days, 3 months, 6 months, 1 year, and 2 years post-surgery to monitor AVF condition and sounds. During the study, participants will be assessed through imaging and sound analysis to measure blood flow patterns and their relationship with AVF vibrations and sounds. Researchers will track the correlation between blood flow disturbances and sound features at each visit. The study will measure how well sound analysis can indicate AVF health over two years, helping develop new, non-invasive monitoring tools. Safety and health status will be regularly checked throughout the follow-up period.
CONDITIONS
Blood Flow Conditions and Sounds in AVFs
M
Michela Bozzetto
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Mario Negri Institute for Pharmacological Research
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (screening and enrollment visit)
Duration - Day 0
Participants undergo surgery for vascular access (arteriovenous fistula creation).
1 visit (in-person surgery visit)
Duration - Up to 2 years after surgery
Participants are monitored with diagnostic tests and assessments to study blood flow conditions and sounds in the arteriovenous fistula.
Visits at day 14, 3 months, 6 months, 1 year, and 2 years after surgery
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/28288599/Mario Negri Institute for Pharmacological Research
Lead Sponsor