An observational study in Middle Cerebral Artery Occlusion, Intracranial Atherosclerosis and Cerebrovascular Disease, sponsored by Qianfoshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Qianfoshan Hospital · Observational
Restoration of arterial patency following recanalization of non-acute atherosclerotic middle cerebral artery (MCA) occlusion may improve cerebral blood supply. However, the extent to which restored perfusion is accompanied by changes in cerebral metabolism and functional brain network organization remains incompletely understood.
This prospective observational study, RESTORE, aims to characterize cerebral perfusion-metabolism recoupling and functional network recovery in patients with non-acute atherosclerotic MCA occlusion who undergo clinically indicated recanalization.
Integrated positron emission tomography/magnetic resonance imaging (PET/MR) will be used to assess cerebral perfusion, metabolic activity, and brain functional connectivity at protocol-defined time points. Imaging measurements will be evaluated in relation to vascular characteristics, recanalization status, and neurological and cognitive outcomes, as applicable.
The study seeks to clarify the temporal and spatial relationships among reperfusion, metabolic changes, and functional network reorganization, and to explore imaging markers associated with clinical recovery after recanalization.
The decision to perform recanalization and the selection of treatment strategies will be based on routine clinical care and will not be assigned by the observational study protocol.
Background and Rationale: Non-acute atherosclerotic MCA occlusion can result in persistent cerebral hypoperfusion, altered metabolic activity, and disruption of functional brain networks. Although recanalization can restore arterial patency in selected patients, anatomical reopening of an occluded artery does not necessarily indicate complete restoration of tissue-level perfusion, cerebral metabolism, or neuronal network function.
Cerebral perfusion and metabolism are closely related under physiological conditions. Chronic hypoperfusion may disrupt this relationship, while successful revascularization may facilitate subsequent physiological adaptation. The timing, magnitude, and distribution of perfusion-metabolism recoupling after recanalization remain uncertain.
Integrated PET/MR allows complementary evaluation of cerebral hemodynamics, tissue metabolic activity, structural abnormalities, and functional connectivity. Its multimodal capabilities may provide a more comprehensive assessment of cerebral recovery than vascular imaging alone.
40 studies on the registry are indexed under Infarction, Middle Cerebral Artery; 6 are open to participants now.
Browse Infarction, Middle Cerebral Artery studies →Qianfoshan Hospital is the lead sponsor of 144 studies on the registry; 75 are open to participants now.
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The study population will consist of patients with non-acute atherosclerotic MCA occlusion who are evaluated for recanalization at participating clinical centers.
Eligible patients undergoing clinically indicated recanalization will be invited to participate in prospective PET/MR imaging assessments and clinical follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change in Perfusion-Metabolism Abnormality Burden in the Affected Hemisphere From Baseline to 1 Month After Recanalization (ΔPMB)
The cerebral perfusion-metabolism coupling index will be derived from spatially corresponding cerebral perfusion and PET-based metabolic measurements within prespecified regions of interest in the affected MCA territory. The exact coupling metric, its calculation, normalization, and interpretation will be defined in the prespecified imaging analysis protocol. The primary measure will be the within-participant change in this index between baseline and the specified follow-up visit.
Time frame: Baseline and 1 Month After Recanalization;
Change in Regional Cerebral Blood Flow From Baseline to 1 Month After Recanalization;
Cerebral blood flow (CBF) in the affected hemisphere will be quantified using arterial spin labeling (ASL) MRI, expressed in mL/100 g/min. The change in CBF will be calculated as the value at 1 month after recanalization minus the preoperative baseline value.
Time frame: Preoperative baseline and 1 month after recanalization.
Change in Arterial Cerebral Blood Volume in the Affected Hemisphere
Arterial cerebral blood volume (aCBV) in the affected hemisphere will be quantified using the prespecified ASL-derived imaging method. The change in aCBV will be calculated as the value at 1 month after recanalization minus the preoperative baseline value.
Time frame: Baseline and 1 Month After Recanalization;
Change in Arterial Transit Time in the Affected Hemisphere
Arterial transit time (ATT) will be quantified using the prespecified ASL MRI technique and expressed in milliseconds. The change in ATT will be calculated as the value at 1 month after recanalization minus the preoperative baseline value.
Time frame: Baseline and 1 Month After Recanalization;
Change in 18F-FDG Standardized Uptake Value Ratio in the Affected Hemisphere
Cerebral glucose metabolism will be assessed using 18F-fluorodeoxyglucose (18F-FDG) PET. The standardized uptake value ratio (SUVR) will be calculated using the prespecified reference region and expressed as a dimensionless ratio. The change in SUVR will be calculated as the value at 1 month after recanalization minus the preoperative baseline value.
Time frame: Baseline and 1 Month After Recanalization;
Change in Hemispheric Asymmetry Index of Cerebral Blood Flow
The hemispheric asymmetry index of cerebral blood flow (CBF-AI) will be calculated from corresponding CBF measurements in the affected and contralateral hemispheres using the prespecified asymmetry formula. The change will be calculated as the index at 1 month after recanalization minus the baseline index.
Time frame: Baseline and 1 Month After Recanalization;
Change in Hemispheric Asymmetry Index of Arterial Cerebral Blood Volume
The hemispheric asymmetry index of arterial cerebral blood volume (aCBV-AI) will be derived from aCBV measurements in the affected and contralateral hemispheres using the prespecified asymmetry formula. The change will be calculated as the index at 1 month after recanalization minus the baseline index.
Time frame: Baseline and 1 Month After Recanalization;
Change in Hemispheric Asymmetry Index of Arterial Transit Time
The hemispheric asymmetry index of arterial transit time (ATT-AI) will be calculated from ATT measurements in the affected and contralateral hemispheres using the prespecified asymmetry formula. The change will be calculated as the index at 1 month after recanalization minus the baseline index.
Time frame: Baseline and 1 Month After Recanalization;
Change in Hemispheric Asymmetry Index of 18F-FDG Standardized Uptake Value Ratio
Change in Hemispheric Asymmetry Index of 18F-FDG Standardized Uptake Value Ratio
Time frame: Baseline and 1 Month After Recanalization;
Proportion of Brain Regions Showing Spatially Concordant Perfusion and Metabolic Improvement After Recanalization
Integrated PET/MR will be used to identify regions of interest (ROIs) exhibiting both perfusion improvement and metabolic improvement at 1 month after recanalization compared with preoperative baseline. Spatial coupling will be quantified as the percentage of evaluable ROIs demonstrating concordant improvement in both parameters, according to prespecified quantitative thresholds and spatial matching criteria.
Time frame: Baseline and 1 Month After Recanalization;
Change in Global Efficiency of Resting-State Functional Brain Networks
Resting-state functional MRI will be used to construct whole-brain functional connectivity networks. Global efficiency will be calculated using graph-theoretical analysis as a quantitative measure of network-wide information integration. The change in global efficiency will be calculated as the value at 1 month after recanalization minus the preoperative baseline value.
Time frame: Baseline and 1 Month After Recanalization;
Change in Interhemispheric Functional Connectivity Strength
Interhemispheric functional connectivity will be assessed using resting-state blood oxygen level-dependent (BOLD) MRI. Connectivity strength between prespecified corresponding regions in the two hemispheres will be quantified using Fisher z-transformed correlation coefficients. The change will be calculated as the value at 1 month after recanalization minus the preoperative baseline value.
Time frame: Baseline and 1 Month After Recanalization;
Change in Nodal Efficiency of Prespecified Brain Network Hubs
Nodal efficiency of prespecified key brain regions will be calculated from resting-state functional connectivity networks using graph-theoretical analysis. Changes in nodal efficiency will be evaluated by comparing measurements obtained before recanalization and at 1 month after recanalization. The regions of interest and the summary metric will be defined in the prespecified imaging analysis protocol.
Time frame: Preoperative baseline and 1 month after recanalization.
Correlation Between 1-Month Change in Perfusion-Metabolism Abnormality Burden and Modified Rankin Scale Score at 90 Days
The association between the change in perfusion-metabolism abnormality burden (ΔPMB) from baseline to 1 month after recanalization and functional disability at 90 days will be assessed. Functional disability will be measured using the modified Rankin Scale (mRS), ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability. The association will be quantified using a prespecified correlation coefficient.
Time frame: Preoperative baseline and 1 month after recanalization.
Correlation Between 1-Month Change in Perfusion-Metabolism Abnormality Burden and Barthel Index Score at 90 Days
The association between ΔPMB from baseline to 1 month after recanalization and activities of daily living at 90 days will be assessed. Functional independence will be measured using the Barthel Index (BI), ranging from 0 to 100, with higher scores indicating greater independence in activities of daily living. The association will be quantified using a prespecified correlation coefficient.
Time frame: Preoperative baseline, 1 month after recanalization (ΔPMB), and 90 days after recanalization (Barthel Index).
Correlation Between 1-Month Change in Perfusion-Metabolism Abnormality Burden and EQ-5D Health Utility Index at 90 Days
The association between ΔPMB from baseline to 1 month after recanalization and health-related quality of life at 90 days will be assessed using the EuroQol 5-Dimension (EQ-5D) questionnaire. EQ-5D responses will be converted into a health utility index using the prespecified instrument version and population-specific value set. Higher utility scores generally indicate better health-related quality of life. The association will be quantified using a prespecified correlation coefficient.
Time frame: Preoperative baseline, 1 month after recanalization (ΔPMB), and 90 days after recanalization (EQ-5D).
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