Signal Intensity Gradient in Cerebral Arteries

Completed

• Conditions: Ischemic Stroke, Acute
• Interventions: Diagnostic Test: Signal intensity gradient

• Registration Number: NCT05495191
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-10
• Primary Completion: 2022-05-05
• Study Completion: 2022-07-23
• Status Verified: 2022-08
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Grouped as the favorable outcome	Signal intensity gradient	\<3 mRS of discharge or 7th day in the patients with the lenticulostriate artery infarction
Grouped as the unfavorable outcome	Signal intensity gradient	≥3 mRS of discharge or 7th day in the patients with the lenticulostriate artery infarction

Primary Outcome Measures

Name	Time	Method
Change of signal intensity gradient at discharge or 7th day in the patients with the lenticulostriate artery infarction	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.

Trial Locations

Locations (1)

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of