Clinical trial NCT06383182: Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion
Official title: Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion: a Prospective, Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute anterior circulation large vessel occlusion within 24 hours of onset who will receive endovascular treatment

Brief summary: Acute ischaemic stroke (AIS) results in high rates of neurological morbidity and mortality, especially in patients with large vessel occlusion (LVO). Endovascular therapy (EVT) has been approved as the most effective treatment for patients with LVO , but about half patients undergoing EVT did not achieve good outcome. The mechanisms of poor prognosis are complex. How to accurately identify serological biomarkers related to patients' clinical prognosis is an important research topic nowadays.


Eligibility criteria: Inclusion Criteria:

1. Age: 18-80 years;
2. Patients with acute anterior circulation large vessel occlusion within 24 hours of onset who will receive endovascular treatment;
3. Pre-stroke mRS: 0-1;
4. Baseline NIHSS: ≥6;
5. Signed informed consent.

Exclusion Criteria:

1. The presence of contraindications to internal jugular vein cannulation;
2. Receiving intravenous thrombolysis;
3. Haemorrhagic stroke (cerebral haemorrhage or subarachnoid haemorrhage);
4. Coagulation disorders, systemic bleeding tendency, thrombocytopenia (\<100×109/L);
5. Severe cardiac, hepatic or renal insufficiency (ALT or AST elevated more than 2 times the upper limit of normal value, or serum creatinine elevated more than 1.5 times the upper limit of normal value or in need of dialysis) or other serious medical diseases;
6. Severe uncontrolled hypertension (systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg);
7. Pregnant or lactating women;
8. Other conditions who are not suitable for this trial by investigator.

Primary outcomes:
measure: Dynamic changes in serum biomarkers after endovascular treatment
timeFrame: from the baseline to immediately, 30 minutes, 6 hours, and 24 hours after endovascular treatment
Secondary outcomes:
measure: favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2
timeFrame: 90±7 days
measure: excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1
timeFrame: 90±7 days
measure: distribution of modified Rankin Scale (mRS) score
timeFrame: 90±7 days
measure: early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)
timeFrame: 24±8 hours
measure: changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 24±8 hours
measure: symptomatic intracranial hemorrhage (sICH)
timeFrame: 24±8 hours
measure: occurence of new stroke or other vascular events
timeFrame: 90±7 days
Other outcomes:
measure: the association between cerebral circulation time (CCT) and clinical outcomes
timeFrame: 24±8 hours, 10±2 days, 90±7 days
measure: the association between serum biomarkers and clinical outcomes
timeFrame: 24±8 hours, 10±2 days, 90±7 days
measure: the association between serum biomarkers and status of vessel recanalization
timeFrame: 24±8 hours, 10±2 days, 90±7 days
Locations:
city: ShenYang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
References: