Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 213000, China
Location status: Recruiting
NCT Number: NCT06457217
The goal of this observational study is to understand acute anterior circulation large artery occluded minor stroke (LVO-MIS) evolution using magnetic resonance spectroscopic imaging evaluation. The main questions it aims to answer are:
1. Neurometabolic predictors of early neurological deterioration and functional outcome; 2. Temporal and spatial dynamic changes of the neurometabolites from the acute stage (within 24 hours), through the subacute stage (5-7 days), to the chronic stage (90 days); 3. Temporal and spatial dynamic changes of the neurotransmitters GABA, glutamate, and glutamine from the acute stage to the chronic stage; 4. Brain regions exhibiting changes in whole-brain metabolic network connectivity.
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Request Info18 year–100 year
All sexes
Observational
Shanghai, Shanghai Municipality, 213000, China
Location status: Recruiting
Minor acute ischemic stroke (AIS) is a common medical condition accounting for more than 50% of AIS. Of the patients with minor AIS, 28.3% are unable to discharge home, and 28.5% cannot walk independently. Although most patients with large vessel occlusion (LVO) strokes and mild symptoms have good clinical outcomes, individuals with early neurological worsening tend to do poorly despite rescue thrombectomy. Therefore, it would be ideal to understand the factors associated with acute neurological deterioration ≥4 NIHSS points among this population to potentially triage higher risk individuals to upfront endovascular therapy.
The main goal of this study was to investigate the spatial and temporal changes of neurometabolite concentrations in patients with acute mild ischemic stroke with large vessel occlusion (LVO-MIS) and to assess the extent to which the combination of all neurometabolite signals measured by 3D-MRSI could discriminate between early neurologic deterioration (END) and non-END patients.
Patients who are older than 18 years of age diagnosed with acute mild ischemic stroke with large vessel occlusion (LVO-MIS) within 24 hours of onset will be enrolled into the study. MRSI will be performed in enrolled stroke patients from the acute stage (within 24 hours), through the subacute stage (5-7 days), to the chronic stage (90 days). Higher resolution 3D MRSI scans were performed using SPICE. The acquisition parameters were as follows: TR = 160 msec, TE = 1.6 msec, spatial resolution = 2.0 × 3.0 × 3.0 mm3, FOV = 240 × 240 × 120 mm3, scan time = 18:35 min.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-resolution 3D metabolic imaging was performed using the SPICE 1H-MRSI sequence.
Time frame: 24 hours
It is defined as an increase of ≥4 points from baseline NIHSS at hospital arrival, and excluding non-ischemic causes such as hemorrhagic transformation and epilepsy.
Time frame: 90 days
Modified Rankin Scale (mRS) score is used to measure the degree of disability in patients who have had a stroke, as follows 0: No symptoms at all
Time frame: acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)
Signals of NAA, lactate, choline, creatine, and myo-inositol were evaluated using MRSI technology
Time frame: acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)
Signal of GABA, glutamate, and glutamine determined by MRSI technology
Time frame: acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)
Changes of metabolic connectivity mapping in whole brain between acute stage and chronic stage of stroke.
Contact information is provided by the study sponsor or research team.
Jiangshan Deng, phD
CONTACT
Li Cao, phD
CONTACT
Shanghai 6th People's Hospital
Other
Magnetic Resonance Spectroscopic Imaging Evaluation for Understanding Acute Minor Stroke With Large Vessel Occlusion Evolution Study
Acronym: MINORITY
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