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

NCT04585971 | Unknown

• 1 other identifier: SIGBF
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Blood Flow

Keywords

Endothelial shear stress; signal-intensity gradient; phase contrast MRI; Time-of-Flight MRI; Carotid Doppler sonography

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow correlation

  Cerebral blood flow correlation between 3 tests (SIG, PC MR, US)

  After completion of recruitment, average 1 year

Study Arms (1)

Subjects

Cerebral blood flow of a subject is measured using three methods in both common carotid and vertebral arteries. 1) Phase-contrast MR 2) Doppler sonography 3) Signal Intensity Gradient (SIG) To determine whether there is a correlation between the measured values, the correlation coefficient is calculated and analyzed.

Diagnostic Test: Signal intensity gradient

Interventions

Signal intensity gradient DIAGNOSTIC_TEST

Signal intensity gradient: In time-of-flight (TOF) MRA, The signal intensities at the iso-point (Φa; signal intensity at position A \[Xa\] along the arterial contour line) and at the inner point (Φb; 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 = (Φb - Φa) / │Xb - Xa│ (1) Vector SIG, SI/mm = (Φb - Φa) n / │Xb - Xa│ (2)

Also known as: Time-of-flight magnetic resonance imaging, Carotid Doppler sonography

Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the neurology department of a tertiary center

You may qualify if:

• 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
• Among the patients (1) who underwent carotid artery Doppler ultrasound
• Patients who fully understand the research objectives and procedures and wish to participate in clinical research voluntarily
• If a patient is not fully understood due to a decrease in awareness or consciousness, the consent of the legal representative is required

You may not qualify if:

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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead
• Medi Image, Inc: collaborator

Study Sites (1)

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Related Publications (5)

• 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.

  PMID: 28900625 BACKGROUND

• 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.

  PMID: 31856692 BACKGROUND

• 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.

  PMID: 24829599 BACKGROUND

• Lee CH, Lee SH, Kwak HS, Rosenson RS, Jeong SK, Jung KH. Arterial flow volume measurement using signal intensity gradient versus phase contrast. Sci Rep. 2025 Dec 29;15(1):44848. doi: 10.1038/s41598-025-28379-7.

  PMID: 41461703 DERIVED

• Lee CH, Lee SH, Kwak HS, Kwak YG, Rosenson RS, Cho YI, Jeong SK. Validation of Signal Intensity Gradient from TOF-MRA for Wall Shear Stress by Phase-Contrast MR. J Imaging Inform Med. 2024 Jun;37(3):1248-1258. doi: 10.1007/s10278-024-00991-5. Epub 2024 Feb 8.

  PMID: 38332403 DERIVED

Study Officials

• Chan-Hyuk Lee, Prof.

  Jeonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan-Hyuk Lee, Prof.

CONTACT

+82-063-250-1590; bluewave0210@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: September 3, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)