Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCapital Medical University

About this trial

Endovascular Thrombectomy has emerged as a pivotal treatment modality for acute ischemic stroke. However, despite successful thrombus removal, a substantial proportion of patients still experience poor outcomes. Selective intra-arterial cooling has shown promise in decelerating stroke progression and providing neuroprotection. This study aims to identify biomarkers associated with the combination of selective intra-arterial cooling infusion and endovascular thrombectomy in the treatment of ischemic stroke by integrating proteomics and metabolomics data. Our study is based on the multicenter RCT study "Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke." All samples were derived from this experiment. Our objective is to elucidate the molecular mechanisms underlying the prognostic impact of this combined therapeutic approach, providing insights to optimize stroke treatment strategies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤80.

Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.

NIHSS score obtained prior to randomization ≥6 and ≤25.

Modified Rankin Scale ≤ 1 prior to qualifying stroke.

Disqualifiers

Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.

Baseline CT/MRI confirms the presence of arterial dissection.

Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.

Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.

Trial population

Blood samples were collected from patients who underwent Endovascular Thrombectomy alone and those who received selective intra-arterial cooling infusion combined with Endovascular Thrombectomy. The supernatant was separated by centrifugation and stored in a -80°C refrigerator.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • hypothermia

    Procedure/Surgery

    Patients who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to either the control group or the IA-SCI group. Control group patients will receive BMM and EVT. IA-SCI group patients will receive BMM and EVT, and additionally a selective intraarterial cooling infusion. The specific method is as follows: * Pre-recanalization: During the procedure, a micro-catheter used to deploy the stent retriever is threaded coaxially into the common femoral artery through the guide catheter. The microcatheter is advanced over a microguide wire, traveling up through the neck until it reaches beyond the clot. A 50 mL cold 0.9% saline (4℃) is infused into the ischemic territory at a rate of 10 mL/min via the microcatheter. This enables the cold solution to infuse into the ischemic territory prior to revascularization. * Post-recanalization: Following vessel recanalization, cold 0.9% saline (4 ℃) is reinfused into the vessel via the catheter at a rate of 22 mL

Treatment groups

258 Participants
are divided into 2 treatment groups
Group A: Control Group0 interventions
Group B: IA-SCI group1 intervention

Trial outcomes

Primary outcomes

1

Primary Outcome

Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics. Measure Description: By integrating proteomics and metabolomics data, researchers were able to identify common pathways and mechanisms through which selective intra-arterial cooling infusion combined with endovascular thrombectomy influences the prognosis of ischemic stroke. Time Frame:3 months

Time frame
2024-10-2025-2

Secondary outcomes

1

Secondary Outcome

1. Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools. 2. All of the omics data were used to compare proteins/enzymes with metabolic pathways. 3. By integrating proteomics and metabolomics data, researchers were able to identify common pathways and mechanisms through which selective intra-arterial cooling infusion combined with endovascular thrombectomy influences the prognosis of ischemic stroke. Time Frame:3 months

Time frame
2024-10-2025-2

Other outcomes

Sponsors and contacts

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