MRSI Evaluation for Minor Stroke With Large Vessel Occlusion

NCT06457217 | Recruiting

• 1 other identifier: MRSI20240309(1)
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 1.Neurometabolic predictors of early neurological deterioration and functional outcome;
2. 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. 3.Temporal and spatial dynamic changes of the neurotransmitters GABA, glutamate, and glutamine from the acute stage to the chronic stage;
4. 4.Brain regions exhibiting changes in whole-brain metabolic network connectivity.

Conditions

Acute Ischemic Stroke

Keywords

Magnetic resonance spectroscopic imaging; Clinical Deterioration; Neurotransmitter; Neurometabolite; Metabolic network connectivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Neurological functional outcome

  90 days

• Composite Temporal and spatial dynamic changes of the neurometabolites

  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

  acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)

• Changes in whole-brain metabolic network connectivity

  acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)

Study Arms (1)

LVO-MIS

Acute minor ischemic stroke induced by large vessel occlusion (LVO-MIS) within 24 hours

Diagnostic Test: Magnetic resonance spectroscopic imaging

Interventions

Magnetic resonance spectroscopic imaging DIAGNOSTIC_TEST

High-resolution 3D metabolic imaging was performed using the SPICE 1H-MRSI sequence.

LVO-MIS

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• Patients with mild symptoms at admission (National Institutes of Health Stroke Scale (NIHSS)\<6);
• Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital;
• Time from symptom onset or last known normal to enrollment is less than 24 hours;
• Patient or legal representative willing to comply with protocol requirements and data collection procedures, understand and sign informed consent.

You may not qualify if:

• A pre-incident mRS ≥ 1 point before onset;
• Previous clear history of cerebral infarction, cerebral hemorrhage, brain tumor and other diseases that affect cerebral metabolism;
• Intolerance or non-cooperation with magnetic resonance examination;
• Severe cardiac, hepatic, renal impairment or other systemic serious advanced diseases;
• Pregnancy or lactation;
• Life expectancy is less than 3 months;
• 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).

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 213000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Clinical Deterioration

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Li Cao, phD

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Cao, phD

CONTACT

+86 21 64369263; caoli2000@yeah.net

Jiangshan Deng, phD

CONTACT

+86 21 64369181; johnson120@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)