Cerebral Blood FlowNCT04585971
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
An observational study of Cerebral Blood Flow, run by Chonbuk National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Blood Flow
- What is being tested?
- Signal intensity gradient
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Sep 2020to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the neurology department of a tertiary center
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Chan-Hyuk Lee, Prof., +82-010-2822-9803, bluewave0210@gmail.com
About this study
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
- Being tested
- Signal intensity gradient
- Keywords
- Endothelial shear stress, signal-intensity gradient, phase contrast MRI, Time-of-Flight MRI, Carotid Doppler sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signal intensity gradientDiagnostic test
Also called Time-of-flight magnetic resonance imaging, Carotid Doppler sonography
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Signal intensity gradient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow correlation
Cerebral blood flow correlation between 3 tests (SIG, PC MR, US)
Measured: After completion of recruitment, average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start3 Sep 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral Blood FlowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medi Image, Inc
- Responsible party
- Principal investigator, Chan-Hyuk Lee, Chonbuk National University Hospital
- Investigators
- Chan-Hyuk Lee, Prof., Principal investigator, Jeonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585971
- Sponsor's protocol ID
- SIGBF
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28900625Lee 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.
PubMed 31856692Jeong 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.
PubMed 24829599Lee 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.
PubMed 41461703Lee 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.
PubMed 38332403
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04585971
- Acronym / sponsor ID
- SIGBF
- Conditions
- Cerebral Blood Flow
- Keywords
- Endothelial shear stress, signal-intensity gradient, phase contrast MRI, Time-of-Flight MRI, Carotid Doppler sonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- Medi Image, Inc
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Diagnostic Test: Signal intensity gradientCerebral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the neurology department of a tertiary center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signal intensity gradientAlso: Time-of-flight magnetic resonance imaging, Carotid Doppler sonographySignal 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) | Diagnostic test | Subjects |
Primary outcome
Cerebral blood flow correlation
Time frame: After completion of recruitment, average 1 year
Cerebral blood flow correlation between 3 tests (SIG, PC MR, US)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 28900625Han 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.
- Background: PubMed 31856692Lee 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.
- Background: PubMed 24829599Jeong 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.
- Derived from this study: PubMed 41461703Lee 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.
- Derived from this study: PubMed 38332403Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chan-Hyuk Lee, Prof. principal investigator
Jeonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Blood Flow, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chan-Hyuk Lee, Prof. (+82-063-250-1590, bluewave0210@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow correlation (time frame: After completion of recruitment, average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585971, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.