Aneurysmal RuptureNCT05450939
Characteristics of Signal Intensity Gradient in Subarachnoid Hemorrhage After Aneurysmal Rupture
An observational study of Aneurysmal Rupture, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
10-20% of patients with subarachnoid hemorrhage die before they arrive at the hospital, and about 25% die within 24 hours. About 1% of patients are diagnosed with cerebral aneurysms in imaging tests for health checkups, and many of them experience aneurysmal rupture during their lifetime, so it is not a rare disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Rupture
- What is being tested?
- Signal intensity gradient
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Nov 2021to 31 Dec 2023
- 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 visited health checkup program or neurology clinic (unruptured group), or emergency department (ruptured group) of a tertiary center
Who may be able to join
- 1) Patients over 18 years of age who visited our hospital for acute subarachnoid hemorrhage due to rupture of a intracranial aneurysm (2) Among patients satisfying (1), who had intracranial magnetic resonance imaging (time-of-flight (TOF) technique applied; diffusion-weighted imaging, including apparent diffusion coefficient) before subarachnoid hemorrhage occurred.
- Magnetic resonance imaging performed during the screening period (Time-of-Flight (TOF) technique is applied to intracranial vessel imaging; It also includes diffusion-weighted imaging and apparent diffusion coefficient)
- Patients diagnosed with unruptured intracranial aneurysm in the final reading of brain MR test
- Patients who remain without aneurysmal rupture on follow-up intracranial magnetic resonance imaging
Who cannot join
- Patients under the age of 18
- Patients with subarachnoid hemorrhage due to causes other than rupture of intracranial aneurysm
- Patients with poor imaging quality due to artifacts caused by patient movement during brain magnetic resonance imaging examination
- <Unruptured group>
- Patients under the age of 18
- Patients with poor imaging quality due to artifacts caused by patient movement during brain magnetic resonance imaging examination
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
Official title: Analysis of Hemodynamic Characteristics Using Signal Intensity Gradient of Brain Magnetic Resonance Imaging in Patients With Subarachnoid Hemorrhage After Rupture of Intracranial Aneurysm
10-20% of patients with subarachnoid hemorrhage die before they arrive at the hospital, and about 25% die within 24 hours. About 1% of patients are diagnosed with cerebral aneurysms in imaging tests for health checkups, and many of them experience aneurysmal rupture during their lifetime, so it is not a rare disease. Wall shear stress is known to be a factor that reflects the state of blood vessels, and particularly plays an important role in the patency of the intima of blood vessels. In the meantime, computed fluid dynamics (CFD), a representative method for calculating wall shear stress, assumes a virtual rigid pipe and applies a preset value. This does not accurately reflect the physiological and dynamic state of the actual blood vessel. The investigators intend to measure the patient's wall shear stress using the SIG of the MRA-TOF technique, which reflects the physiological characteristics of individual patients, and to analyze the association with rupture of the intracranial aneurysm.
- Conditions
- Aneurysmal Rupture
- Being tested
- Signal intensity gradient
- Keywords
- Signal intensity gradient, Wall shear stress, Aneurysmal rupture, Time-of-Flight MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signal intensity gradientDiagnostic test
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 |
|---|---|---|
| Ruptured group | Group of subarachnoid hemorrhage after rupture of intracranial aneurysm Receives: Diagnostic Test: Signal intensity gradient | |
| Unruptured group | Group of inexperience of aneurysmal rupture during specific period Receives: Diagnostic Test: Signal intensity gradient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of signal intensity gradient in aneurysmal sac
The investigators will measure the degree of signal intensity gradient (SIG) from brain TOF-MRA in aneurysmal sac.
The measured SIG in ruptured group would be lower than that in unruptured group.
Measured: Average 4-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start25 Nov 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal RuptureStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan-Hyuk Lee, Chonbuk National University Hospital
- Investigators
- Chan-Hyuk Lee, Dr., Principal investigator, Jeonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450939
- Sponsor's protocol ID
- SIGSAH
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2022
- Last updated
- 11 Jul 2022
- 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 28900625Suzuki T, Stapleton CJ, Koch MJ, Tanaka K, Fujimura S, Suzuki T, Yanagisawa T, Yamamoto M, Fujii Y, Murayama Y, Patel AB. Decreased wall shear stress at high-pressure areas predicts the rupture point in ruptured intracranial aneurysms. J Neurosurg. 2019 Mar 15;132(4):1116-1122. doi: 10.3171/2018.12.JNS182897. Print 2020 Apr 1.
PubMed 30875692Lee 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 31856692Lee CH, Kwak HS, Kang HS, Jung KH, Jeong SK. Geometric versus Hemodynamic Indexes for Rupture-Destined Aneurysms: A Retrospective Cohort and a Repeated-Measures Study. Cerebrovasc Dis. 2024;53(3):327-334. doi: 10.1159/000533167. Epub 2023 Sep 11.
PubMed 37696264
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Hemodynamic Characteristics Using Signal Intensity Gradient of Brain Magnetic Resonance Imaging in Patients With Subarachnoid Hemorrhage After Rupture of Intracranial Aneurysm
- ClinicalTrials.gov ID
- NCT05450939
- Acronym / sponsor ID
- SIGSAH
- Conditions
- Aneurysmal Rupture
- Keywords
- Signal intensity gradient, Wall shear stress, Aneurysmal rupture, Time-of-Flight MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Jul 2022 (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.
10-20% of patients with subarachnoid hemorrhage die before they arrive at the hospital, and about 25% die within 24 hours. About 1% of patients are diagnosed with cerebral aneurysms in imaging tests for health checkups, and many of them experience aneurysmal rupture during their lifetime, so it is not a rare disease. Wall shear stress is known to be a factor that reflects the state of blood vessels, and particularly plays an important role in the patency of the intima of blood vessels. In the meantime, computed fluid dynamics (CFD), a representative method for calculating wall shear stress, assumes a virtual rigid pipe and applies a preset value. This does not accurately reflect the physiological and dynamic state of the actual blood vessel. The investigators intend to measure the patient's wall shear stress using the SIG of the MRA-TOF technique, which reflects the physiological characteristics of individual patients, and to analyze the association with rupture of the intracranial aneurysm.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruptured group | – | Diagnostic Test: Signal intensity gradientGroup of subarachnoid hemorrhage after rupture of intracranial aneurysm |
| Unruptured group | – | Diagnostic Test: Signal intensity gradientGroup of inexperience of aneurysmal rupture during specific period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visited health checkup program or neurology clinic (unruptured group), or emergency department (ruptured group) of a tertiary center
Key inclusion criteria (4 listed)
- 1) Patients over 18 years of age who visited our hospital for acute subarachnoid hemorrhage due to rupture of a intracranial aneurysm (2) Among patients satisfying (1), who had intracranial magnetic resonance imaging (time-of-flight (TOF) technique applied; diffusion-weighted imaging, including apparent diffusion coefficient) before subarachnoid hemorrhage occurred.
- Magnetic resonance imaging performed during the screening period (Time-of-Flight (TOF) technique is applied to intracranial vessel imaging; It also includes diffusion-weighted imaging and apparent diffusion coefficient)
- Patients diagnosed with unruptured intracranial aneurysm in the final reading of brain MR test
- Patients who remain without aneurysmal rupture on follow-up intracranial magnetic resonance imaging
Key exclusion criteria (6 listed)
- Patients under the age of 18
- Patients with subarachnoid hemorrhage due to causes other than rupture of intracranial aneurysm
- Patients with poor imaging quality due to artifacts caused by patient movement during brain magnetic resonance imaging examination
- <Unruptured group>
- Patients under the age of 18
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 gradientIn 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 | Ruptured group, Unruptured group |
Primary outcome
Degree of signal intensity gradient in aneurysmal sac
Time frame: Average 4-6 years
The investigators will measure the degree of signal intensity gradient (SIG) from brain TOF-MRA in aneurysmal sac. The measured SIG in ruptured group would be lower than that in unruptured group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- 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 30875692Suzuki T, Stapleton CJ, Koch MJ, Tanaka K, Fujimura S, Suzuki T, Yanagisawa T, Yamamoto M, Fujii Y, Murayama Y, Patel AB. Decreased wall shear stress at high-pressure areas predicts the rupture point in ruptured intracranial aneurysms. J Neurosurg. 2019 Mar 15;132(4):1116-1122. doi: 10.3171/2018.12.JNS182897. Print 2020 Apr 1.
- 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.
- Derived from this study: PubMed 37696264Lee CH, Kwak HS, Kang HS, Jung KH, Jeong SK. Geometric versus Hemodynamic Indexes for Rupture-Destined Aneurysms: A Retrospective Cohort and a Repeated-Measures Study. Cerebrovasc Dis. 2024;53(3):327-334. doi: 10.1159/000533167. Epub 2023 Sep 11.
- 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, Dr. 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 Aneurysmal Rupture, 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 6 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 11 Jul 2022. 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, Dr. (+82-10-2822-9803, bluewave0210@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of signal intensity gradient in aneurysmal sac (time frame: Average 4-6 years). 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 NCT05450939, which also lists 4 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 11 Jul 2022.