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

Launched by CAPITAL MEDICAL UNIVERSITY · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating acute ischemic stroke, which happens when a blood vessel supplying blood to the brain is blocked. The treatment being tested combines two methods: endovascular thrombectomy, which removes the blood clot, and selective intra-arterial cooling, which lowers the temperature in the affected area of the brain to protect it. Researchers want to find out if there are specific biological markers that can help predict how well patients will respond to this combined treatment, using advanced techniques to analyze proteins and metabolites in the body.

To participate in this study, individuals should be between 18 and 80 years old and have clear signs of a stroke caused by a blockage in a major blood vessel in the brain. They should have a certain level of stroke severity and must be treated within a specific time frame after their symptoms started. Participants will undergo both the clot removal procedure and the cooling treatment, and their progress will be monitored closely. It’s important for potential participants to discuss any health conditions or medications with their doctors to determine if they meet the eligibility requirements. This study could help improve future stroke treatments and outcomes for patients.

Gender

ALL

Eligibility criteria

• 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.