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Integrated PET/MR Assessment of Brain Recovery After Recanalization of Non-Acute Atherosclerotic MCA Occlusion

4 de novembro de 2026 atualizado por: Han Ju, Qianfoshan Hospital

RESTORE: A Prospective Observational Study of Perfusion-Metabolism Recoupling and Functional Network Recovery After Recanalization of Non-Acute Atherosclerotic Middle Cerebral Artery Occlusion Using Integrated PET/MR

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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

15

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Shandong
      • Jinan, Shandong, China, 261053
        • Recrutamento
        • The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
        • Contato:
        • Investigador principal:
          • Ju Han, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

Inclusion Criteria:

  1. Aged 18-80 years, regardless of sex.
  2. Symptomatic non-acute middle cerebral artery (MCA) occlusion, with an interval of ≥4 weeks between the most recent ischemic event or imaging confirmation of occlusion and the recanalization procedure.
  3. Occlusion involving the M1 segment of the MCA, confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
  4. Occlusion presumed to be of atherosclerotic origin.
  5. Persistence of at least one of the following despite guideline-directed medical therapy: recurrent transient ischemic attacks (TIAs), minor ischemic stroke, symptoms attributable to cerebral hypoperfusion, watershed infarction, or imaging evidence of cerebral hypoperfusion or metabolic abnormalities.
  6. Preoperative PET/MR images of sufficient quality for quantitative analysis.
  7. Clinically scheduled to undergo endovascular recanalization.
  8. Provision of written informed consent by the patient or their legally authorized representative.

Exclusion Criteria:

  1. Acute large-territory cerebral infarction involving more than one-third of the MCA territory.
  2. Extensive encephalomalacia within the affected vascular territory that precludes reliable assessment of cortical regions of interest (ROIs).
  3. Non-atherosclerotic causes of MCA occlusion, including moyamoya disease, arterial dissection, central nervous system vasculitis, or cardioembolism.
  4. Severe bilateral intracranial arterial occlusive disease that precludes reliable calculation of hemispheric asymmetry indices.
  5. Structural lesions involving the cerebellum or brainstem that may interfere with metabolic analysis using the cerebellum as a reference region.
  6. Contraindications to MRI (e.g., incompatible cardiac pacemakers, metallic foreign bodies, or severe claustrophobia) or PET imaging.
  7. Severe head motion or imaging artifacts that render PET/MR, arterial spin labeling (ASL), or blood oxygen level-dependent (BOLD) imaging data unsuitable for analysis.
  8. Poor glycemic control (fasting blood glucose >11.1 mmol/L) that may compromise the quality of 18F-fluorodeoxyglucose (18F-FDG) PET imaging.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: COHORT
  • Perspectivas de Tempo: PROSPECTIVE

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Perfusion-Metabolism Abnormality Burden in the Affected Hemisphere From Baseline to 1 Month After Recanalization (ΔPMB)
Prazo: Baseline and 1 Month After Recanalization;

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.
Baseline and 1 Month After Recanalization;

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Regional Cerebral Blood Flow From Baseline to 1 Month After Recanalization;
Prazo: Preoperative baseline and 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.
Preoperative baseline and 1 month after recanalization.
Change in Arterial Cerebral Blood Volume in the Affected Hemisphere
Prazo: Baseline and 1 Month After Recanalization;

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.
Baseline and 1 Month After Recanalization;
Change in Arterial Transit Time in the Affected Hemisphere
Prazo: Baseline and 1 Month After Recanalization;

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.
Baseline and 1 Month After Recanalization;
Change in 18F-FDG Standardized Uptake Value Ratio in the Affected Hemisphere
Prazo: Baseline and 1 Month After Recanalization;

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.
Baseline and 1 Month After Recanalization;
Change in Hemispheric Asymmetry Index of Cerebral Blood Flow
Prazo: Baseline and 1 Month After Recanalization;

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.
Baseline and 1 Month After Recanalization;
Change in Hemispheric Asymmetry Index of Arterial Cerebral Blood Volume
Prazo: Baseline and 1 Month After Recanalization;

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.
Baseline and 1 Month After Recanalization;
Change in Hemispheric Asymmetry Index of Arterial Transit Time
Prazo: Baseline and 1 Month After Recanalization;

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.
Baseline and 1 Month After Recanalization;
Change in Hemispheric Asymmetry Index of 18F-FDG Standardized Uptake Value Ratio
Prazo: Baseline and 1 Month After Recanalization;

Change in Hemispheric Asymmetry Index of 18F-FDG Standardized Uptake Value Ratio
Baseline and 1 Month After Recanalization;
Proportion of Brain Regions Showing Spatially Concordant Perfusion and Metabolic Improvement After Recanalization
Prazo: Baseline and 1 Month 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.
Baseline and 1 Month After Recanalization;
Change in Global Efficiency of Resting-State Functional Brain Networks
Prazo: Baseline and 1 Month After Recanalization;

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.
Baseline and 1 Month After Recanalization;
Change in Interhemispheric Functional Connectivity Strength
Prazo: Baseline and 1 Month After Recanalization;

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.
Baseline and 1 Month After Recanalization;
Change in Nodal Efficiency of Prespecified Brain Network Hubs
Prazo: Preoperative baseline and 1 month after recanalization.

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.
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
Prazo: Preoperative baseline and 1 month after recanalization.

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.
Preoperative baseline and 1 month after recanalization.
Correlation Between 1-Month Change in Perfusion-Metabolism Abnormality Burden and Barthel Index Score at 90 Days
Prazo: Preoperative baseline, 1 month after recanalization (ΔPMB), and 90 days after recanalization (Barthel Index).

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.
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
Prazo: Preoperative baseline, 1 month after recanalization (ΔPMB), and 90 days after recanalization (EQ-5D).

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.
Preoperative baseline, 1 month after recanalization (ΔPMB), and 90 days after recanalization (EQ-5D).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Qianfoshan Hospital

Investigadores

  • Investigador principal: Ju Han, MD, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

21 de março de 2024

Conclusão Primária (Estimado)

1 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

4 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de novembro de 2026

Primeira postagem (Real)

10 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RESTORE

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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