Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT06383182
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-20
• Study First Posted: 2024-04-25
• Status Verified: 2024-07
• Study Start: 2024-07-02
• Last Update Submitted: 2024-07-06
• Last Update Posted: 2024-07-09
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dynamic changes in serum biomarkers after endovascular treatment	from the baseline to immediately, 30 minutes, 6 hours, and 24 hours after endovascular treatment	These biomarkers will be identified based on proteomic methods

Secondary Outcome Measures

Name	Time	Method
favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2	90±7 days	mRS ranges from 0-6, high score means poor outcome
distribution of modified Rankin Scale (mRS) score	90±7 days	mRS ranges from 0-6, high score means poor outcome
early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)	24±8 hours	NIHSS ranges from 0-22, with high score meaning severe neurological deficit.
occurence of new stroke or other vascular events	90±7 days
excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1	90±7 days	mRS ranges from 0-6, high score means poor outcome
changes in National Institute of Health stroke scale (NIHSS)	24±8 hours	NIHSS ranges from 0-22, with high score meaning severe neurological deficit.
symptomatic intracranial hemorrhage (sICH)	24±8 hours	sICH is defined as an increase in 4 or more points on the NIHSS

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 ShenYang, China