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

To Assess the Value of 3D Time-of-Flight Magnetic Resonance Angiography in Hemodialysis Patients With Occlusive Disease in Arteriovenous Fistula

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Arteriovenous Fistula Stenosis; Magnetic Resonance Angiography
• Intervention / Treatment: Diagnostic test: 3D-TOF-MRA

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200023
    • Shanghai 6th People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: intervention; All participants received 3D-TOF-MRA and ultrasound examination, and DSA is used as golden reference

Diagnostic test: 3D-TOF-MRA; 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. 3D-TOF-MRA is a non-invasive and safe method for diagnosing vascular diseases.; Other Names: Ultrasound; Digital Substraction Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of stenosis	visual grading system: 0 = completely smooth vessel wall; = <50% stenosis;; = 50%-75% stenosis;; = 75%-99% stenosis;; = occlusion.	immediately after examination finished
stenosis location	= arterial vessel of AVF; = orifice of AVF; = venous vessel of AVF	immediately after examination finished

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Investigators: Principal Investigator: Yue-Qi Zhu, Dr, Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: Shanghai 6th People's Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be made avaliable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No