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RecruitingNCT06457217

MRSI Evaluation for Minor Stroke With Large Vessel Occlusion

Magnetic Resonance Spectroscopic Imaging Evaluation for Understanding Acute Minor Stroke With Large Vessel Occlusion Evolution Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
75 (estimated)
Sponsor
Shanghai 6th People's Hospital · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMagnetic resonance spectroscopic imagingHigh-resolution 3D metabolic imaging was performed using the SPICE 1H-MRSI sequence.

Timeline

Start date
2024-08-15
Primary completion
2027-09-30
Completion
2027-12-30
First posted
2024-06-13
Last updated
2024-10-16

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06457217. Inclusion in this directory is not an endorsement.