search
Back to results

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

Primary Purpose

Magnetic Resonance Angiography, Hemodialysis, Arteriovenous Fistula Stenosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D-TOF-MRA
Sponsored by
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Magnetic Resonance Angiography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai 6th People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention

Arm Description

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

Outcomes

Primary Outcome Measures

degree of stenosis
visual grading system: 0 = completely smooth vessel wall; = <50% stenosis; = 50%-75% stenosis; = 75%-99% stenosis; = occlusion.
stenosis location
= arterial vessel of AVF = orifice of AVF = venous vessel of AVF

Secondary Outcome Measures

Full Information

First Posted
March 12, 2020
Last Updated
January 5, 2022
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04312711
Brief Title
3D Time-of-Flight Magnetic Resonance Angiography in Hemodialysis Patients With Arteriovenous Fistula
Official Title
To Assess the Value of 3D Time-of-Flight Magnetic Resonance Angiography in Hemodialysis Patients With Occlusive Disease in Arteriovenous Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnetic Resonance Angiography, Hemodialysis, Arteriovenous Fistula Stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
All participants received 3D-TOF-MRA and ultrasound examination, and DSA is used as golden reference
Intervention Type
Diagnostic Test
Intervention Name(s)
3D-TOF-MRA
Other Intervention Name(s)
Ultrasound, Digital Substraction Angiography
Intervention 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. 3D-TOF-MRA is a non-invasive and safe method for diagnosing vascular diseases.
Primary Outcome Measure Information:
Title
degree of stenosis
Description
visual grading system: 0 = completely smooth vessel wall; = <50% stenosis; = 50%-75% stenosis; = 75%-99% stenosis; = occlusion.
Time Frame
immediately after examination finished
Title
stenosis location
Description
= arterial vessel of AVF = orifice of AVF = venous vessel of AVF
Time Frame
immediately after examination finished

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue-Qi Zhu, Dr
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai 6th People's Hospital
City
Shanghai
ZIP/Postal Code
200023
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made avaliable.

Learn more about this trial

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

We'll reach out to this number within 24 hrs