Clinical trial NCT06665386: Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.
Official title: Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Hypothermia Treatment
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.


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.

Primary outcomes:
measure: Primary Outcome
timeFrame: 2024-10-2025-2
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 2024-10-2025-2
Other outcomes:
Locations:
city: Da Lian
country: China
facility: Dalian Municipal Central Hospital
state: Liao Ning
Study officials:
References: