Clinical trial NCT05450939: Characteristics of Signal Intensity Gradient in Subarachnoid Hemorrhage After Aneurysmal Rupture
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysmal Rupture
Keywords: Signal intensity gradient
Wall shear stress
Aneurysmal rupture
Time-of-Flight MRI
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visited health checkup program or neurology clinic (unruptured group), or emergency department (ruptured group) of a tertiary center

Brief 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. 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.


Eligibility criteria: \<Ruptured group\>

Inclusion Criteria:

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.

Exclusion Criteria:

1. Patients under the age of 18
2. Patients with subarachnoid hemorrhage due to causes other than rupture of intracranial aneurysm
3. Patients with poor imaging quality due to artifacts caused by patient movement during brain magnetic resonance imaging examination

\<Unruptured group\>

Inclusion Criteria:

1. 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)
2. Patients diagnosed with unruptured intracranial aneurysm in the final reading of brain MR test
3. Patients who remain without aneurysmal rupture on follow-up intracranial magnetic resonance imaging

Exclusion Criteria:

1. Patients under the age of 18
2. Patients with poor imaging quality due to artifacts caused by patient movement during brain magnetic resonance imaging examination

Primary outcomes:
measure: Degree of signal intensity gradient in aneurysmal sac
timeFrame: Average 4-6 years
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, Dr.
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: Suzuki 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.
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.