Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.
NCT ID: NCT06665386
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
258 participants
OBSERVATIONAL
2024-10-27
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Control Group
Patients will receive best medical management (BMM) plus EVT according to the clinical guidelines.
No interventions assigned to this group
IA-SCI group
Patients will receive BMM and EVT combined with selective intra-arterial cold saline infusion.
hypothermia
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
Interventions
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hypothermia
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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
MD.PhD
Locations
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Dalian Municipal Central Hospital
Dalian, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Di Li
Role: primary
Other Identifiers
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PBIA
Identifier Type: -
Identifier Source: org_study_id