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

Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion: a Prospective, Registry Study

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Procedure: endovascular treatment

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • ShenYang, China, 110840
    • Recruiting
    • General Hospital of Northern Theater Command
    • Contact: Zi-Ai Zhao; Phone Number: 86-2428897517; Email: zhaoziai@hotmail.com
    • Contact: Yu Cui; Phone Number: 86-24-28897499; Email: cuiyu.spu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the association between cerebral circulation time (CCT) and clinical outcomes	CCT is defined as the time from the appearance of contrast at the siphon segment of the internal carotid to the end of the arterial phase during DSA on the anteroposterior and lateral image in anterior circulation LVO; clinical outcomes include changes in NIHSS and mRS	24±8 hours, 10±2 days, 90±7 days
the association between serum biomarkers and clinical outcomes	serum biomarkers include those in different timepoints or their dynamic changes; clinical outcomes include changes in NIHSS and mRS	24±8 hours, 10±2 days, 90±7 days
the association between serum biomarkers and status of vessel recanalization	serum biomarkers include those in different timepoints or their dynamic changes; the status of vessel recanalization is determined by modified thrombolysis in cerebral infarction	24±8 hours, 10±2 days, 90±7 days

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 20, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: Y (2024) 054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No