Characteristics of Signal Intensity Gradient in Subarachnoid Hemorrhage After Aneurysmal Rupture

NCT05450939 | Unknown

• 1 other identifier: SIGSAH
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Rupture

Keywords

Signal intensity gradient; Wall shear stress; Aneurysmal rupture; Time-of-Flight MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  Average 4-6 years

Study Arms (2)

Ruptured group

Group of subarachnoid hemorrhage after rupture of intracranial aneurysm

Diagnostic Test: Signal intensity gradient

Unruptured group

Group of inexperience of aneurysmal rupture during specific period

Diagnostic Test: Signal intensity gradient

Interventions

Signal intensity gradient DIAGNOSTIC_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)

Ruptured group; Unruptured group

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 visited health checkup program or neurology clinic (unruptured group), or emergency department (ruptured group) of a tertiary center

You may qualify if:

• \) 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.

You may not qualify if:

• 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\>
• 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
• Patients under the age of 18
• Patients with poor imaging quality due to artifacts caused by patient movement during brain magnetic resonance imaging examination

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Related Publications (4)

• 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

• 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.

  PMID: 30875692 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

• Lee 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.

  PMID: 37696264 DERIVED

Study Officials

• Chan-Hyuk Lee, Dr.

  Jeonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan-Hyuk Lee, Dr.

CONTACT

+82-10-2822-9803; bluewave0210@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 11, 2022
• Study Start: November 25, 2021
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)