Ischemic StrokeNCT06383182
Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion
An observational study of Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- endovascular treatment
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2024to 30 Dec 2027
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with acute anterior circulation large vessel occlusion within 24 hours of onset who will receive endovascular treatment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, 110840
Zi-Ai Zhao, 86-2428897517, zhaoziai@hotmail.com
Yu Cui, 86-24-28897499, cuiyu.spu@hotmail.com
About this study
Official title: 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.
- Conditions
- Ischemic Stroke
- Being tested
- endovascular treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular treatmentProcedure or surgery
all patients with anterior circulation large vessel occlusion will receive endovascular treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes in serum biomarkers after endovascular treatment
These biomarkers will be identified based on proteomic methods
Measured: from the baseline to immediately, 30 minutes, 6 hours, and 24 hours after endovascular treatment
Secondary outcomes (7)
favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2
mRS ranges from 0-6, high score means poor outcome
Measured: 90±7 days
excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1
mRS ranges from 0-6, high score means poor outcome
Measured: 90±7 days
distribution of modified Rankin Scale (mRS) score
mRS ranges from 0-6, high score means poor outcome
Measured: 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.
Measured: 24±8 hours
changes in National Institute of Health stroke scale (NIHSS)
NIHSS ranges from 0-22, with high score meaning severe neurological deficit.
Measured: 24±8 hours
symptomatic intracranial hemorrhage (sICH)
sICH is defined as an increase in 4 or more points on the NIHSS
Measured: 24±8 hours
occurence of new stroke or other vascular events
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start2 Jul 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383182
- Sponsor's protocol ID
- Y (2024) 054
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion: a Prospective, Registry Study
- ClinicalTrials.gov ID
- NCT06383182
- Acronym / sponsor ID
- Y (2024) 054
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with acute anterior circulation large vessel occlusion within 24 hours of onset who will receive endovascular treatment
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular treatmentall patients with anterior circulation large vessel occlusion will receive endovascular treatment. | Procedure or surgery | – |
Primary outcome
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
7 secondary outcomes
favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2
Time frame: 90±7 days
excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1
Time frame: 90±7 days
distribution of modified Rankin Scale (mRS) score
Time frame: 90±7 days
early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)
Time frame: 24±8 hours
changes in National Institute of Health stroke scale (NIHSS)
Time frame: 24±8 hours
symptomatic intracranial hemorrhage (sICH)
Time frame: 24±8 hours
occurence of new stroke or other vascular events
Time frame: 90±7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.