Arterial Wall Shear Stress After Intracranial Artery Recanalization

NCT06290271 | Recruiting

• 1 other identifier: CISTAR
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Intracranial Artery Occlusion

Keywords

Wall Shear Stress; Intracranial Artery Occlusion; Signal Intensity Gradient

Outcome Measures

Primary Outcomes (1)

• Neurological Severity at discharge

  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.

Study Arms (2)

Passive Group

The cerebral blood flow pattern normalizes after the recanalization of the occluded artery

Other: Intracranial artery flow pattern

Active Group

The overall major cerebral blood flow increases after the recanalization of the occluded artery

Other: Intracranial artery flow pattern

Interventions

Intracranial artery flow pattern OTHER

the cerebral blood flow patterns observed after the occluded artery has been recanalized.

Active Group; Passive Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead
• Seoul National University Hospital: collaborator
• Chungnam National University Hospital: collaborator
• Asan Medical Center: collaborator
• Chonnam National University Hospital: collaborator
• Korea University Ansan Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (8)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 15355, South Korea

NOT YET RECRUITING

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

NOT YET RECRUITING

Chungnam National University Hospital

Daejeon, 35015, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

NOT YET RECRUITING

Ulsan University Hospital

Ulsan, 44033, South Korea

RECRUITING

Study Officials

• Keun-Hwa Jung, Prof.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Hee Jung Song, Prof.

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan-Hyuk Lee, Prof.

CONTACT

+82-052-250-7089; bluewave0210@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: March 4, 2024
• Study Start: August 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

KR (8)