Identifying biomarkers for cooling therapy combined with thrombectomy in stroke treatment
Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.
This study is trying to find specific markers in the blood that can help doctors understand how well a cooling treatment combined with a clot removal procedure works for people having a stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 258 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Dalian, Liaoning) |
| Trial ID | NCT06665386 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with acute ischemic stroke who undergo endovascular thrombectomy, a procedure to remove blood clots. It aims to explore the prognostic biomarkers associated with the combination of selective intra-arterial cooling infusion and thrombectomy, utilizing proteomics and metabolomics data. By analyzing samples from a multicenter randomized controlled trial, the study seeks to understand the molecular mechanisms that could enhance treatment strategies for stroke patients. The goal is to improve patient outcomes by identifying effective biomarkers that predict the success of this combined therapeutic approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with acute ischemic stroke and large vessel occlusion in the anterior circulation.
Not a fit: Patients with multiple vascular territory strokes, arterial dissection, or evidence of intracranial hemorrhage prior to thrombectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for stroke patients, potentially enhancing recovery and reducing long-term disability.
How similar studies have performed: While the approach of combining cooling therapy with thrombectomy is promising, the specific integration of proteomics and metabolomics in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dalian, Liaoning
- Dalian Municipal Central Hospital — Dalian, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Xunming Ji, Professor
- Email: chenxi00cx@126.com
- Phone: +86 17600104266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.