Arterial Wall Shear Stress After Intracranial Artery Recanalization

February 29, 2024 updated by: Chan-Hyuk Lee, Chonbuk National University Hospital

Correlation Between Changes in Arterial Wall Shear Stress and Prognosis Following Acute Major Intracranial Artery Occlusion and Recanalization

There has been consistent research on the cerebral blood flow features in ischemic stroke patients with acute occlusion of major intracranial arteries. However, studies analyzing the overall features of the major intracranial artery blood flow in the periods of pre and post-recanalization are still lacking. Time-of-flight magnetic resonance angiography (TOF-MRA) is extensively utilized to evaluate the intracranial arteries. The arterial signal intensity from MRA-TOF varies across subjects and arterial subtypes, leading to the development of the Signal Intensity Gradient (SIG) concept. SIG has demonstrated a strong correlation with Computational Fluid Dynamics (CFD), a known method for reflecting wall shear stress. SIG could be associated with the pathophysiology of wall shear stress. We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Background The prognosis for ischemic stroke patients experiencing acute major intracranial artery occlusion is determined by a variety of factors. The status of arterial recanalization and the time taken to achieve recanalization play pivotal roles in determining patient outcomes. Even under similar conditions, short or long-term outcomes significantly differ among patients, making it challenging to solely explain with traditional risk factors. An acute occlusion in a major intracranial artery results in significant alterations in cerebral blood flow, enhancing flow through the Circle of Willis and collateral circulation to make up for the reduced blood supply to the affected area. After thrombectomy, the patterns of intracranial blood flow. changes again.

    Wall Shear Stress (WSS) is the frictional resistance force exerted by blood flow as it directly interacts with the vascular walls, and it serves as a critical indicator of vascular health. WSS is well-known for its correlation with atherosclerotic changes. Studies have shown that WSS in the internal carotid artery of ischemic stroke patients is lower compared to healthy individuals. Additionally, WSS was found to be reduced in the carotid artery of patients with lacunar infarctions. WSS in large artery strokes was lower than in the cardioembolic group. There have also been reports linking WSS to the progression of Moyamoya disease, suggesting that WSS may be associated with various vascular pathophysiologies, not just atherosclerotic changes.

    Time-of-Flight Magnetic Resonance Angiography (TOF-MRA) is a commonly used brain MRI technique, often utilized in conjunction with CT angiography to assess the course and condition of intracranial arteries. The signal intensity from MRA-TOF presents diverse distributions across different subjects and arteries. Based on this, the concept of Signal Intensity Gradient (SIG) has been derived. SIG has shown a strong correlation (correlation coefficient >0.8) with Computational Fluid Dynamics (CFD), a well-known method for assessing blood shear stress. In patients with the large artery atherosclerosis subtype of stroke, the SIG in the ipsilateral internal carotid artery was significantly lower than that on the contralateral side. These findings suggest a potential association between SIG, vascular shear stress, and the related pathophysiology.

    There is no need for additional imaging beyond TOF, and it is possible to measure even arteries of relatively small diameter. Therefore, SIG enables the analysis of shear stress pattern in major cerebral arteries before and after recanalization.

  2. Aims We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG.
  3. Target number of participants A total of 160 participants (20 individuals from each center, total 8 centers)
  4. Sample size assessment Although there haven't been many similar studies in the past, a study (PLoS One. 2020 Sep 21;15(9):e0238620) conducted a hemodynamic evaluation before and after major vessel recanalization, analyzing 11 patients. Sample size estimation using G*Power indicated that registration of approximately 144 patients would be necessary. Taking into account factors such as image quality, we anticipate an additional recruitment of about 10%, resulting in a final target of 160 cases.

  5. Data Acquisition This study is a retrospective cohort study that involves the collection of electronic medical records and imaging data.

    Imaging Data to be Collected: (All images will be collected as DICOM files)

    • Brain MRI (Specific imaging conditions: Fluid Attenuated Inversion Recovery, Susceptibility Weighted Imaging, T1-Weighted Imaging, T2-Weighted Imaging, Diffusion Weighted Imaging, Apparent Diffusion Coefficient)
    • Brain MRA (Specific imaging conditions: source images from both extra and intracranial TOF-MRA, and 3D TOF-MRA)

  6. Derivation of Intravascular Shear Stress (SIG) Through Image Analysis The transferred DICOM files are reconstructed into 3D vasculature using a separate software (VINT).

    SIG values for the major arterial segments within the cranial cavity are extracted.

    The major arterial segments are as follows, and the points where laminar flow of blood is formed were selected, considering the characteristics of the SIG technique:

    • Internal Carotid Artery: C1 distal segment prior to the horizontal intrapetrous segment
    • Vertebral Artery: V4 distal segment just before the formation of the basilar artery
    • Basilar Artery: mid to distal segment
    • Middle and Anterior Cerebral Arteries: proximal 1/2 or 1/3 segment
    • Posterior Cerebral Artery: P2 segment distal to the posterior communicating artery The measurements can be calculated into various SIG values (average, maximum, minimum, deviation).
  7. Statistical Analysis Each patient will be classified into two groups based on their blood flow characteristics before and after recanalization. In a preliminary study, two types of blood flow (shear stress) changes were observed. Firstly, there was a pattern in which, following cerebral vascular occlusion, blood flow to the ischemic area was provided, and upon recanalization, it returned to the typical blood flow pattern. Secondly, there was a case where the overall blood flow in the major cerebral vessels increased after recanalization. To analyze these patterns, Paired t-test and Wilcoxon Signed-Rank Test will be used. (While this study is expected to proceed in the same manner as the group classification in the preliminary study, the classification method may be revised as the research progresses.)

For comparing mean values between groups, Independent Samples t-Test and Mann-Whitney U Test will be utilized. Categorical variables will be analyzed using the Chi-square Test or Fisher's Exact Test. Variables such as mRS (modified Rankin Scale), which are ordinal, will be assessed using the Mann-Whitney U Test or Wilcoxon Rank-Sum Test to utilize the median values.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 35015
        • Recruiting
        • Chungnam national university hospital
        • Contact:
      • Gwangju, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of, 07061
        • Not yet recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
      • Ulsan, Korea, Republic of, 44033
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of, 15355
        • Not yet recruiting
        • Korea University Ansan Hospital
        • Contact:
    • Jeollabuk Do
      • Jeonju, Jeollabuk Do, Korea, Republic of, 54907
        • Not yet 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who presented to a medical center with acute neurological deficits and were confirmed to have acute occlusion in a major cerebral artery.

Description

Inclusion Criteria:

  • Individuals aged 18 years and above
  • Presenting with acute neurological impairments and demonstrating occlusion of major cerebral arteries (inclusive of one or more of the internal carotid artery, anterior cerebral artery, middle cerebral artery, posterior cerebral artery, vertebral artery, or basilar artery) as evidenced by brain MRA examinations
  • Arterial recanalization subsequent to interventions such as intravenous thrombolysis and/or endovascular thrombectomy.
  • Verification of the recanalized arteries on subsequent brain MRA imging
  • Availability of source images from intracranial TOF-MRA (stored in DICOM format) both before and after arterial recanalization

Exclusion Criteria:

  • Absence of TOF-MRA imaging either before or after arterial recanalization
  • Brain MRI was performed, but TOF-MRA (DICOM source images) are missing
  • Image analysis is deemed challenging due to the quality of the Brain MR images
  • Intervention for vascular recanalization was unsuccessful, or re-occlusion was observed in the follow-up brain MRA

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Passive Group
The cerebral blood flow pattern normalizes after the recanalization of the occluded artery
Other: Intracranial artery flow pattern
the cerebral blood flow patterns observed after the occluded artery has been recanalized.
Active Group
The overall major cerebral blood flow increases after the recanalization of the occluded artery
Other: Intracranial artery flow pattern
the cerebral blood flow patterns observed after the occluded artery has been recanalized.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neurological Severity at discharge
Time Frame: The Modified Rankin Scale (mRS) was assessed on the 7th day after admission.
Modified Rankin Scale (mRS, 0-5, higher scores mean a worse outcome) measured at discharge
The Modified Rankin Scale (mRS) was assessed on the 7th day after admission.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chonbuk National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Asan Medical Center
Chonnam National University Hospital
Seoul National University Hospital
SMG-SNU Boramae Medical Center
Chungnam National University Hospital
Korea University Ansan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keun-Hwa Jung, Prof., Seoul National University Hospital
  • Principal Investigator: Hee Jung Song, Prof., Chungnam national university hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CISTAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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