Characteristics of Signal Intensity Gradient in Subarachnoid Hemorrhage After Aneurysmal Rupture

July 8, 2022 updated by: Chan-Hyuk Lee, Chonbuk National University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

<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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ruptured group
Group of subarachnoid hemorrhage after rupture of intracranial aneurysm
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)
Unruptured group
Group of inexperience of aneurysmal rupture during specific period
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average 4-6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Investigators

  • Principal Investigator: Chan-Hyuk Lee, Dr., Jeonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2021

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 8, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIGSAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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