MRSI Evaluation for Minor Stroke With Large Vessel Occlusion (MINORITY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Diagnostic test: Magnetic resonance spectroscopic imaging

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.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Li Cao, phD; Phone Number: +86 21 64369263; Email: caoli2000@yeah.net
• Study Contact Backup: Name: Jiangshan Deng, phD; Phone Number: +86 21 64369181; Email: johnson120@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 213000
      • Recruiting
      • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Jiangshan Deng, MD; Email: johnson120@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Adult (age ≥ 18 years) patients presenting with symptoms consistent with acute ischemic stroke due to occlusion of the intracranial internal carotid artery and/or M1 or M2 segment of the middle cerebral artery;
2. Patients with mild symptoms at admission (National Institutes of Health Stroke Scale (NIHSS)<6);
3. Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital;
4. Time from symptom onset or last known normal to enrollment is less than 24 hours;
5. Patient or legal representative willing to comply with protocol requirements and data collection procedures, understand and sign informed consent.

Exclusion Criteria:

1. A pre-incident mRS ≥ 1 point before onset;
2. Previous clear history of cerebral infarction, cerebral hemorrhage, brain tumor and other diseases that affect cerebral metabolism;
3. Intolerance or non-cooperation with magnetic resonance examination;
4. Severe cardiac, hepatic, renal impairment or other systemic serious advanced diseases;
5. Pregnancy or lactation;
6. Life expectancy is less than 3 months;
7. Other conditions that, in the opinion of the investigator, are not suitable for participation in this study or may pose a significant risk to the patient (such as inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional disorders).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LVO-MIS; Acute minor ischemic stroke induced by large vessel occlusion (LVO-MIS) within 24 hours	Diagnostic test: Magnetic resonance spectroscopic imaging; High-resolution 3D metabolic imaging was performed using the SPICE 1H-MRSI sequence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early neurological deterioration	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological functional outcome	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; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	90 days
Composite Temporal and spatial dynamic changes of the neurometabolites	Signals of NAA, lactate, choline, creatine, and myo-inositol were evaluated using MRSI technology	acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)
Composite Temporal and spatial dynamic changes of the neurotransmitters	Signal of GABA, glutamate, and glutamine determined by MRSI technology	acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)
Changes in whole-brain metabolic network connectivity	Changes of metabolic connectivity mapping in whole brain between acute stage and chronic stage of stroke.	acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Investigators: Principal Investigator: Li Cao, phD, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Neurotransmitter; Clinical Deterioration; Magnetic resonance spectroscopic imaging; Neurometabolite; Metabolic network connectivity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: MRSI20240309(1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No