An interventional study of 3D-TOF-MRA in Magnetic Resonance Angiography, Hemodialysis and Arteriovenous Fistula Stenosis, sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
267 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
This study's enrollment of 68 is close to the median of 68 across 177 interventional studies indexed under Arteriovenous Fistula.
Browse Arteriovenous Fistula studies →Shanghai Jiao Tong University Affiliated Sixth People's Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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.
Also known as: Ultrasound, Digital Substraction Angiography
degree of stenosis
visual grading system: 0 = completely smooth vessel wall; 1. = \<50% stenosis; 2. = 50%-75% stenosis; 3. = 75%-99% stenosis; 4. = occlusion.
Time frame: immediately after examination finished
stenosis location
1. = arterial vessel of AVF 2. = orifice of AVF 3. = venous vessel of AVF
Time frame: immediately after examination finished
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Plan to share: No — Individual participant data will not be made avaliable.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital