3D Time-of-Flight Magnetic Resonance Angiography in Hemodialysis Patients With Arteriovenous Fistula

Not Applicable

Completed

• Conditions: Arteriovenous Fistula Stenosis; Magnetic Resonance Angiography; Hemodialysis
• Interventions: Diagnostic Test: 3D-TOF-MRA

• Registration Number: NCT04312711
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Brief Summary

This study is aimed to assess the value of three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) in hemodialysis patients with occlusive disease in arteriovenous fistula (AVF). All participants will receive 3D-TOF-MRA and ultrasound to detect the stenosis degree of AVF.

Detailed Description

The Principle of 3D-TOF-MRA is based on the "flow effect" of MR. In the GE sequence of MRA imaging, the effect of RF pulses makes the protons in the stationary tissue in the active layer in a saturated state, and the longitudinal magnetization disappears. When the inflow blood appears, its protons are in an unsaturated state and have a high degree of longitudinal magnetization. In this way, a clear difference is formed between saturated tissue and unsaturated flowing blood to display blood vessels. Therefore as a non-invasive and safe method for diagnosing vascular diseases, 3D-TOF-MRA is used widely in cerebrovascular diseases. However, there are currently no studies using 3D-TOF-MRA to diagnose arteriovenous fistula (AVF) stenosis in hemodialysis patients. This project plans to use 3D-TOF-MRA to detect AVF stenosis in hemodialysis patients to provide a safe and effective diagnostic method for patients with end-stage renal failure.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Primary Completion: 2020-10-01
• Study Completion: 2021-03-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• hemodialysis patients suspected of occlusive disease in arteriovenous fistula (AVF);
• persistent edema of the limb with the fistula;
• decreased pulse or fremitus in anastomotic astium
• increase in venous pressure; blood flow at the access of less than 200 mL/min;

Exclusion Criteria

• previous endovascular recanalization with stent or graft placement;
• contraindications to magnetic resonance imaging (MRI) examination;
• platelet(PLT)<60*10^9/L or international normalized ratio (INR)>1.5; 4. important organ function failure or other serious illness; 5. Allergic to antiplatelet drug, anticoagulant drug, anaesthetic drug and contrast material.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention	3D-TOF-MRA	All participants received 3D-TOF-MRA and ultrasound examination, and DSA is used as golden reference

Primary Outcome Measures

Name	Time	Method
stenosis location	immediately after examination finished	1. = arterial vessel of AVF; 2. = orifice of AVF; 3. = venous vessel of AVF
degree of stenosis	immediately after examination finished	visual grading system: 0 = completely smooth vessel wall; 1. = \<50% stenosis; 2. = 50%-75% stenosis; 3. = 75%-99% stenosis; 4. = occlusion.

Trial Locations

Locations (1)

Shanghai 6th People's Hospital; 🇨🇳 Shanghai, China