Clinical trial NCT04585971: A Study on Hemodynamic Relationship Including Cerebral Blood Flow Using Phase Contrast and Signal Intensity Gradient of Brain Magnetic Resonance Imaging, and Carotid Doppler Ultrasound
Official title: A Study on Hemodynamic Relationship Including Cerebral Blood Flow Using Phase Contrast and Signal Intensity Gradient of Brain Magnetic Resonance Imaging, and Carotid Doppler Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Blood Flow
Keywords: Endothelial shear stress
signal-intensity gradient
phase contrast MRI
Time-of-Flight MRI
Carotid Doppler sonography
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: Medi Image, Inc
First posted: 2020-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the neurology department of a tertiary center

Brief summary: Cerebral blood flow measurement, which is applied to patients with cerebrovascular-related diseases, provides useful information about hemodynamic status. There was a method using Doppler ultrasound and phase contrast (PC) MRI, but it was not widely used in clinical practice due to limitations in reproducibility between examiners, complexity of procedure, and time-intensive protocol. We intend to measure cerebral blood flow through the signal-intensity gradient (SIG) technique using Time-of-Flight (TOF) of brain magnetic resonance imaging, which can compensate for the shortcomings of the existing research methods. In addition, by analyzing the correlation with the previous methods, Doppler ultrasound and PC MRI, we will evaluate the effectiveness of our new method.


Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age or older who have been admitted to the neurology department due to a stroke, and those who have already performed brain magnetic resonance imaging
2. Among the patients (1) who underwent carotid artery Doppler ultrasound
3. Patients who fully understand the research objectives and procedures and wish to participate in clinical research voluntarily
4. If a patient is not fully understood due to a decrease in awareness or consciousness, the consent of the legal representative is required

Exclusion Criteria:

1. Patients whose extracranial artery occlusion or severe stenosis was confirmed in brain magnetic resonance images.
2. Those who judge that the subject is unsuitable for participation in clinical research due to other reasons.

Primary outcomes:
measure: Cerebral blood flow correlation
timeFrame: After completion of recruitment, average 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Chan-Hyuk Lee, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han KS, Lee SH, Ryu HU, Park SH, Chung GH, Cho YI, Jeong SK. Direct Assessment of Wall Shear Stress by Signal Intensity Gradient from Time-of-Flight Magnetic Resonance Angiography. Biomed Res Int. 2017;2017:7087086. doi: 10.1155/2017/7087086. Epub 2017 Aug 16.
citation: Lee WJ, Jeong SK, Han KS, Lee SH, Ryu YJ, Sohn CH, Jung KH. Impact of Endothelial Shear Stress on the Bilateral Progression of Unilateral Moyamoya Disease. Stroke. 2020 Mar;51(3):775-783. doi: 10.1161/STROKEAHA.119.028117. Epub 2019 Dec 20.
citation: Jeong SK, Lee JY, Rosenson RS. Association between Ischemic Stroke and Vascular Shear Stress in the Carotid Artery. J Clin Neurol. 2014 Apr;10(2):133-9. doi: 10.3988/jcn.2014.10.2.133. Epub 2014 Apr 23.