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

Recruiting

• Conditions: Stroke; Hypothermia Treatment

• Registration Number: NCT06665386
• Lead Sponsor: Capital Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-27
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-30
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• 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.
• Arterial puncture performed within 24 hours from symptom onset or LKW.
• For the patients with symptom onset within 6 hours, the ASPECT score ≥6; for the patientswith onset within 6-24 hours, the therapy should meet the imaging criteria of DAWN or DEFUSE-3 trial.
• Patient/Legally Authorized Representative has signed the Informed Consent Form.

Exclusion Criteria

• 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.
• Severe infection (e.g. sepsis) or multiple organ failure.
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3. Patients on factor Xa inhibitor for 48 hours ago must have a normal APTT.
• Baseline platelet count <50 × 109/L.
• Blood glucose concentration<50 mg/dL (2.7mmol/L) or >400 mg/dL (22.2mmol/L).
• Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure>185 mmHg or diastolic blood pressure>110mmHg).
• Previous NHYA>1.
• Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
• Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate <30 ml/min or serum creatinine >220 mmol/L (2.5mg/dl).
• Known intracranial aneurysm, and cerebral arteriovenous malformation.
• Malignant brain tumor or CNS infection.
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
• Female who is pregnant or lactating at time of admission.
• Anticipated life expectancy <6 months.
• Current participation in another investigational drug or device study.
• For other reasons, the responsible clinicians believe that the patient is not suitable for continued treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome	2024-10-2025-2	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

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	2024-10-2025-2	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

Trial Locations

Locations (1)

Dalian Municipal Central Hospital; 🇨🇳 Da Lian, Liao Ning, China