Blood Flow Conditions and Sounds in AVFs

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT06411353
Status
Recruiting
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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • MRI acquisition — DIAGNOSTIC_TEST
    Non-contrast enhanced acquisitions will be performed using a whole-body MRI scanner operating at 1.5 Tesla or greater.
  • US examination — DIAGNOSTIC_TEST
    A complete assessment of the AVF vessels is performed using advanced 3D US procedures.

Study Details

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.

Key Dates

First listed
May 13, 2024
Start date
Mar 1, 2025
Status verified
Aug 2025
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients
    Patients will first undergo visit V1 (screening and enrolment). On day 0 they will have the surgery for VA creation (V2) and then the study follow-up visits will take place i.e., between 0 and 14 days, at 3 months, 6 months, 1 year and 2 years after VA surgery (V3-V7).

Primary Outcome Measure

Correlation coefficient between LHPR and the vein's surface area with OSI > 0.1 [ Time Frame: At each established study visit (i.e., at day 14, at months 3, 6, 12, 24) ]

Central Contacts

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