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NCT Number: NCT06383182

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The presence of contraindications to internal jugular vein cannulation;
  • Receiving intravenous thrombolysis;
  • Haemorrhagic stroke (cerebral haemorrhage or subarachnoid haemorrhage);
  • Coagulation disorders, systemic bleeding tendency, thrombocytopenia (<100×109/L);
  • 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;
  • Severe uncontrolled hypertension (systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg);
  • Pregnant or lactating women;
  • Other conditions who are not suitable for this trial by investigator.

Treatment and study plan

endovascular treatment

Procedure

all patients with anterior circulation large vessel occlusion will receive endovascular treatment.

Primary outcomes

  1. Dynamic changes in serum biomarkers after endovascular treatment

    Time frame: 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 outcomes

  1. favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2

    Time frame: 90±7 days

    mRS ranges from 0-6, high score means poor outcome

  2. excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1

    Time frame: 90±7 days

    mRS ranges from 0-6, high score means poor outcome

  3. distribution of modified Rankin Scale (mRS) score

    Time frame: 90±7 days

    mRS ranges from 0-6, high score means poor outcome

  4. early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)

    Time frame: 24±8 hours

    NIHSS ranges from 0-22, with high score meaning severe neurological deficit.

  5. changes in National Institute of Health stroke scale (NIHSS)

    Time frame: 24±8 hours

    NIHSS ranges from 0-22, with high score meaning severe neurological deficit.

  6. symptomatic intracranial hemorrhage (sICH)

    Time frame: 24±8 hours

    sICH is defined as an increase in 4 or more points on the NIHSS

  7. occurence of new stroke or other vascular events

    Time frame: 90±7 days

Other outcomes

  1. the association between cerebral circulation time (CCT) and clinical outcomes

    Time frame: 24±8 hours, 10±2 days, 90±7 days

    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

  2. the association between serum biomarkers and clinical outcomes

    Time frame: 24±8 hours, 10±2 days, 90±7 days

    serum biomarkers include those in different timepoints or their dynamic changes; clinical outcomes include changes in NIHSS and mRS

  3. the association between serum biomarkers and status of vessel recanalization

    Time frame: 24±8 hours, 10±2 days, 90±7 days

    serum biomarkers include those in different timepoints or their dynamic changes; the status of vessel recanalization is determined by modified thrombolysis in cerebral infarction

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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