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

NCT ID: NCT04312711

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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Magnetic Resonance Angiography Hemodialysis Arteriovenous Fistula Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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intervention

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

Group Type EXPERIMENTAL

3D-TOF-MRA

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Ultrasound Digital Substraction Angiography

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yueqi Zhu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yue-Qi Zhu, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th People's Hospital

Locations

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Shanghai 6th People's Hospital

Shanghai, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Shanghai 6th People's Hospital

Identifier Type: -

Identifier Source: org_study_id

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