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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04312711
Enrollment
68
Registered
2020-03-18
Start date
2018-12-01
Completion date
2021-03-31
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula Stenosis, Hemodialysis, Magnetic Resonance Angiography

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.

Interventions

DIAGNOSTIC_TEST3D-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.

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
degree of stenosisimmediately after examination finishedvisual grading system: 0 = completely smooth vessel wall; 1. = \<50% stenosis; 2. = 50%-75% stenosis; 3. = 75%-99% stenosis; 4. = occlusion.
stenosis locationimmediately after examination finished1. = arterial vessel of AVF 2. = orifice of AVF 3. = venous vessel of AVF

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026