Actively Recruiting
Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.
Led by Capital Medical University · Updated on 2024-12-12
258
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Clinical signs of acute ischemic stroke with large vessel blockage in the anterior circulation confirmed by imaging (CTA, MRA, or DSA)
- NIHSS score between 6 and 25 before randomization
- Modified Rankin Scale score of 1 or less before the qualifying stroke
- Arterial puncture done within 24 hours from symptom onset or last known well
- ASPECT score 6 or higher if within 6 hours of onset; if 6-24 hours, meets imaging criteria of DAWN or DEFUSE-3 trial
- Signed informed consent by patient or legal representative
You will not qualify if you...
- Multiple acute strokes in different brain areas on baseline CT or MRI
- Presence of arterial dissection on baseline imaging
- Intracranial bleeding or hemorrhagic transformation before thrombectomy
- Allergies or intolerance to antiplatelet drugs, anticoagulants, iodinated contrast, or anesthesia
- Severe infection such as sepsis or multiple organ failure
- Known bleeding disorders or recent anticoagulant therapy with high INR; patients on factor Xa inhibitors require normal APTT
- Baseline platelet count below 50 x 10^9/L
- Blood glucose less than 50 mg/dL or greater than 400 mg/dL
- Uncontrolled high blood pressure (systolic over 185 mmHg or diastolic over 110 mmHg)
- Previous New York Heart Association class over 1
- Untreated moderate or severe coronary artery narrowing or prior coronary bypass surgery
- On dialysis or severe kidney failure with low filtration rate or high creatinine
- Known brain aneurysm or arteriovenous malformation
- Malignant brain tumor or central nervous system infection
- Pre-existing neurological or psychiatric conditions affecting assessments
- Pregnant or breastfeeding women at admission
- Life expectancy under 6 months
- Participation in another investigational drug or device study
- Other reasons making patient unsuitable for continued treatment as judged by clinicians
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dalian Municipal Central Hospital
Dalian, Liaoning, China, 116000
Actively Recruiting
Research Team
X
Xunming Ji, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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