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

Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04312711
Collaborator
(none)
68
Enrollment
1
Location
1
Arm
28
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 3D-TOF-MRA
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will receive three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) and ultrasound to detect the stenosis degree of AVF.All participants will receive three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) and ultrasound to detect the stenosis degree of AVF.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
To Assess the Value of 3D Time-of-Flight Magnetic Resonance Angiography in Hemodialysis Patients With Occlusive Disease in Arteriovenous Fistula
Actual Study Start Date :
Dec 1, 2018
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. degree of stenosis [immediately after examination finished]

      visual grading system: 0 = completely smooth vessel wall; = <50% stenosis; = 50%-75% stenosis; = 75%-99% stenosis; = occlusion.

    2. stenosis location [immediately after examination finished]

      = arterial vessel of AVF = orifice of AVF = venous vessel of AVF

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai 6th People's Hospital Shanghai China 200023

    Sponsors and Collaborators

    • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    Investigators

    • Principal Investigator: Yue-Qi Zhu, Dr, Shanghai 6th People's Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Yueqi Zhu, Clinical Professor, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
    ClinicalTrials.gov Identifier:
    NCT04312711
    Other Study ID Numbers:
    • Shanghai 6th People's Hospital
    First Posted:
    Mar 18, 2020
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arteriovenous Fistula
    Fistula

    Study Results

    No Results Posted as of Jan 11, 2022