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RecruitingNCT06383182Updated Sep 17, 2026

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

An observational study in Ischemic Stroke, sponsored by General Hospital of Shenyang Military Region. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by General Hospital of Shenyang Military Region · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ischemic Stroke

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03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 800 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  1. The presence of 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 ( or AST elevated more than 2 times the 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Interventions

  • Procedureendovascular treatment

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

06

What researchers measure

Primary outcomes

  1. Dynamic changes in serum biomarkers after endovascular treatment

    These biomarkers will be identified based on proteomic methods

    Time frame: from the baseline to immediately, 30 minutes, 6 hours, and 24 hours after endovascular treatment

Secondary outcomes

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

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

    Time frame: 90±7 days

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

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

    Time frame: 90±7 days

  3. distribution of modified Rankin Scale (mRS) score

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

    Time frame: 90±7 days

  4. 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.

    Time frame: 24±8 hours

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

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

    Time frame: 24±8 hours

  6. symptomatic intracranial hemorrhage (sICH)

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

    Time frame: 24±8 hours

  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

    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

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

  2. 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

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

  3. 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

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

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Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06383182
Lead sponsor
General Hospital of Shenyang Military Region
Responsible party
Hui-Sheng Chen (Director, General Hospital of Shenyang Military Region) — Principal investigator
First posted
Apr 25, 2024
Start date
Jul 2, 2024
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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