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

NCT04312711 | Completed

• 1 other identifier: Shanghai 6th People's Hospital
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Resonance Angiography; Hemodialysis; Arteriovenous Fistula Stenosis

Outcome Measures

Primary Outcomes (2)

• degree of stenosis

  visual grading system: 0 = completely smooth vessel wall; 1. = \<50% stenosis; 2. = 50%-75% stenosis; 3. = 75%-99% stenosis; 4. = occlusion.

  immediately after examination finished

• stenosis location

  1. = arterial vessel of AVF 2. = orifice of AVF 3. = venous vessel of AVF

  immediately after examination finished

Study Arms (1)

intervention

EXPERIMENTAL

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

Diagnostic Test: 3D-TOF-MRA

Interventions

3D-TOF-MRA DIAGNOSTIC_TEST

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.

Also known as: Ultrasound, Digital Substraction Angiography

intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, 200023, China

Location

MeSH Terms

Interventions

Ultrasonography; Angiography, Digital Subtraction

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Angiography; Radiography; Subtraction Technique; Diagnostic Techniques, Cardiovascular

Study Officials

• Yue-Qi Zhu, Dr

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: All participants will receive three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) and ultrasound to detect the stenosis degree of AVF.

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 18, 2020
• Study Start: December 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: March 31, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)