Acute Ischemic StrokeMINORITYNCT06457217
MRSI Evaluation for Minor Stroke With Large Vessel Occlusion
An observational study of Acute Ischemic Stroke, run by Shanghai 6th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Magnetic resonance spectroscopic imaging
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 30 Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 213000
Jiangshan Deng, MD, johnson120@126.com
About this study
Official title: 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:
- Neurometabolic predictors of early neurological deterioration and functional outcome;
- 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);
- Temporal and spatial dynamic changes of the neurotransmitters GABA, glutamate, and glutamine from the acute stage to the chronic stage;
- Brain regions exhibiting changes in whole-brain metabolic network connectivity.
Read the 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
- Acute Ischemic Stroke
- Being tested
- Magnetic resonance spectroscopic imaging
- Keywords
- Magnetic resonance spectroscopic imaging, Clinical Deterioration, Neurotransmitter, Neurometabolite, Metabolic network connectivity
- Medical subject headings
- Ischemic Stroke, Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance spectroscopic imagingDiagnostic test
High-resolution 3D metabolic imaging was performed using the SPICE 1H-MRSI sequence.
| Study group | Role | What they receive |
|---|---|---|
| LVO-MIS | Acute minor ischemic stroke induced by large vessel occlusion (LVO-MIS) within 24 hours Receives: Diagnostic Test: Magnetic resonance spectroscopic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Aug 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Cao, Shanghai 6th People's Hospital
- Investigators
- Li Cao, phD, Principal investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457217
- Sponsor's protocol ID
- MRSI20240309(1)
- Acronym
- MINORITY
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopic Imaging Evaluation for Understanding Acute Minor Stroke With Large Vessel Occlusion Evolution Study
- ClinicalTrials.gov ID
- NCT06457217
- Acronym / sponsor ID
- MINORITY / MRSI20240309(1)
- Conditions
- Acute Ischemic Stroke
- Keywords
- Magnetic resonance spectroscopic imaging, Clinical Deterioration, Neurotransmitter, Neurometabolite, Metabolic network connectivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Neurometabolic predictors of early neurological deterioration and functional outcome;
- 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);
- Temporal and spatial dynamic changes of the neurotransmitters GABA, glutamate, and glutamine from the acute stage to the chronic stage;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVO-MIS | – | Diagnostic Test: Magnetic resonance spectroscopic imagingAcute minor ischemic stroke induced by large vessel occlusion (LVO-MIS) within 24 hours |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance spectroscopic imagingHigh-resolution 3D metabolic imaging was performed using the SPICE 1H-MRSI sequence. | Diagnostic test | LVO-MIS |
Primary outcome
Early neurological deterioration
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.
4 secondary outcomes
Neurological functional outcome
Time frame: 90 days
Composite Temporal and spatial dynamic changes of the neurometabolites
Time frame: 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
Time frame: acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)
Changes in whole-brain metabolic network connectivity
Time frame: acute stage (within 24 hours), the subacute stage (5-7 days) and the chronic stage (90 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Cao, phD principal investigator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Cao, phD (+86 21 64369263, caoli2000@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early neurological deterioration (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.