Clinical trial NCT05495191: Signal Intensity Gradient in Cerebral Arteries
Official title: Association Between Signal Intensity Gradient of Cerebral Arteries From Time-of-flight Magnetic Resonance Angiography and Clinical Outcome in Patients With Lenticulostriate Artery Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke, Acute
Keywords: Cerebral artery
Lenticulostriate artery infarction
Signal intensity gradient
Signal intensity gradient, Wall shear stress
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: Korean Society of Neurosonology
name: Ministry of SMEs and Startups, Republic of Korea
name: Korean Neurological Association
First posted: 2022-08-10
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change of signal intensity gradient at discharge or 7th day in the patients with the lenticulostriate artery infarction
timeFrame: Approximately 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Chan-Hyuk Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Decavel P, Vuillier F, Moulin T. Lenticulostriate infarction. Front Neurol Neurosci. 2012;30:115-9. doi: 10.1159/000333606. Epub 2012 Feb 14.
citation: Jeong SK, Lee JY, Rosenson RS. Association between Ischemic Stroke and Vascular Shear Stress in the Carotid Artery. J Clin Neurol. 2014 Apr;10(2):133-9. doi: 10.3988/jcn.2014.10.2.133. Epub 2014 Apr 23.
citation: Han KS, Lee SH, Ryu HU, Park SH, Chung GH, Cho YI, Jeong SK. Direct Assessment of Wall Shear Stress by Signal Intensity Gradient from Time-of-Flight Magnetic Resonance Angiography. Biomed Res Int. 2017;2017:7087086. doi: 10.1155/2017/7087086. Epub 2017 Aug 16.