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

Cerebral Blood Flow Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04585971
• Other study ID #: SIGBF
• Status: Recruiting
• Start date: September 3, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: October 2020
• Source: Chonbuk National University Hospital
• Contact: Chan-Hyuk Lee, Prof.
• Phone: +82-063-250-1590
• Email: bluewave0210[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Blood Flow

Intervention

Diagnostic Test:
• Signal intensity gradient
Signal intensity gradient: In time-of-flight (TOF) MRA, The signal intensities at the iso-point (Fa; signal intensity at position A [Xa] along the arterial contour line) and at the inner point (Fb; signal intensity at position B [Xb]) were calculated by using a trilinear interpolation algorithm based on the positions and signal intensities in the eight neighboring voxels. The signal intensities of TOF-MRA were normalized to eliminate the offset and scale effects across the MRA datasets of participants. For each iso-point (position A), the SIG was calculated from the difference in signal intensities between points A and B as follows: Scalar SIG, SI/mm = (Fb - Fa) / ¦Xb - Xa¦ (1) Vector SIG, SI/mm = (Fb - Fa) n / ¦Xb - Xa¦ (2)

Locations

Country	Name	City	State
Korea, Republic of	Jeonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (2)

Lead Sponsor	Collaborator
Chonbuk National University Hospital	Medi Image, Inc

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral blood flow correlation	Cerebral blood flow correlation between 3 tests (SIG, PC MR, US)	After completion of recruitment, average 1 year