Signal Intensity Gradient in Cerebral Arteries

August 8, 2022 updated by: Chonbuk National University Hospital

Association Between Signal Intensity Gradient of Cerebral Arteries From Time-of-flight Magnetic Resonance Angiography and Clinical Outcome in Patients With Lenticulostriate Artery Infarction

Arterial wall shear stress (WSS) contributes to atherosclerosis from its inception, progression, and disruption of plaque. However, there is no previous study for an association between cerebral artery WSS and clinical outcome in patients with ischemic stroke in lenticulostriate artery.

The researchers aimed to investigate whether the signal intensity gradient (SIG) from Time-of-Flight Magnetic Resonance Angiography (TOF MRA) in cerebral arteries, as a surrogate measure of arterial WSS, is associated with clinical outcome, which was determined with modified Rankin Scale (mRS).

The patients (n=294) with the lenticulostriate artery infarction were collected in 3 hospitals with variable locations and sizes (Gunsan, Jeonju, and Seoul). For a clinical outcome, National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) were checked serially from the date of admission. The mRS 2 or less at the 7th day or discharge was defined as a favorable outcome. The arterial SIGs were measured concurrently in both internal carotid, anterior/middle/posterior cerebral, vertebral arteries, and basilar artery from TOF MRA on initial diagnosis. The independent association between the clinical outcome and cerebral arterial SIG was analyzed adjusting for all the possible potential confounders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

294

Contacts and Locations

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

Study Locations

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

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

This study is a multi-center, retrospective cohort study for all consecutive patients. From January 2015 to March 2021, patients who were diagnosed with acute ischemic stroke in the lenticulostriate artery (LSA) territory were registered at three centers (Jeonbuk National University Hospital, Samsung Medical Center, and Gunsan Medical Center). The 3 centers have their own characteristics: Gunsan Medical center is in a small city where about 300,000 citizens live, Jeonbuk National University Hospital is in a medium sized city where about 650,000 citizens live, and Samsung Medical Center is in a capital city where about 10,000,000 citizens live).

Description

Inclusion Criteria:

  1. Patients aged 18 years or older who had brain magnetic resonance imaging (MRI) for acute ischemic stroke within 3 days
  2. Patients who underwent diffusion-weighted imaging (DWI) and apparent diffusion coefficient of the cerebral parenchyma, and cerebral angiographic measurements, in which, intracranial arteries should be examined by time-of-flight (TOF) techniques
  3. A patient with high signal intensity lesions in the unilateral LSA territory on DWI.

Exclusion Criteria:

  1. Patients younger than 18 years of age
  2. Patients with moderate to severe (>50%) stenosis or occlusion of the major intracranial and extracranial arteries, including internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery (BA), and vertebral artery (VA)
  3. Patients whose ischemic stroke was due to or related with cardiac or rare etiology (e.g., arterial dissection, moyamoya disease).

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: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Grouped as the favorable outcome
<3 mRS of discharge or 7th day in the patients with the lenticulostriate artery infarction
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)
Grouped as the unfavorable outcome
≥3 mRS of discharge or 7th day in the patients with the lenticulostriate artery infarction
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
Change of signal intensity gradient at discharge or 7th day in the patients with the lenticulostriate artery infarction
Time Frame: Approximately 1 week
Degrees of the signal intensity gradient (SIG) from brain TOF-MRA in major cerebral arteries are measured in the patients with the lenticulostriate artery infarction at discharge or 7th day.
Approximately 1 week

Collaborators and Investigators

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

Sponsor

Chonbuk National University Hospital

Collaborators

Korean Society of Neurosonology
Ministry of SMEs and Startups, Republic of Korea
Korean Neurological Association

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)

May 10, 2021

Primary Completion (Actual)

May 5, 2022

Study Completion (Actual)

July 23, 2022

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIGLSA

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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