MRI acquisition: Non-contrast enhanced acquisitions will be performed using a whole-body MRI scanner operating at 1.5 Tesla or greater.
US examination: A complete assessment of the AVF vessels is performed using advanced 3D US procedures.
Study summary
This is a prospective non-pharmacological interventional study aimed at investigating the relationship between the blood flow condition and the arteriovenous fistula (AVF) sound, with the ultimate aim of predicting the AVF clinical, in patients with end-stage renal disease (ESRD) who require the creation of a vascular access for extracorporeal circulation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
* Provision of informed consent prior to any study specific procedures.
* Female and/or male aged between 18 and 90 years.
* Patients in HD treatment who need a new VA or patients who entered the pre-dialysis program because of ESRD. In all cases, the first-choice treatment is the surgical creation of an autogenous AVF in patient's forearm.
Exclusion Criteria:
* Contraindications for the creation of an autogenous AVF.
* Presence of a previously failed AVF in the same arm selected for surgery.
* Patients with contraindications to MRI including: pregnancy, claustrophobia, cardiac pacemakers or other MRI-incompatible prostheses.
* Patients already on HD treatment through a catheter or a graft.
* Patients undergoing peritoneal dialysis.
* Patients with a life expectancy of less than 2 years.
Primary outcome measure(s)
Correlation coefficient between LHPR and the vein's surface area with OSI > 0.1 — At each established study visit (i.e., at day 14, at months 3, 6, 12, 24) LHPR: ratio between the amplitude of maximum peak in the range of low-frequency (100-250 Hz) and the amplitude of the maximum peak at high frequency (500-750 Hz). OSI: oscillatory shear index, common metric for disturbed blood flow.
Trial sites (1)
Facility
City
Region
Status
A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi
Bergamo
Bergamo
Recruiting
More Mario Negri Institute for Pharmacological Research trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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