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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383182
• Other study ID #: Y (2024) 054
• Status: Not yet recruiting
• Start date: May 7, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. The mechanisms of poor prognosis are complex. How to accurately identify serological biomarkers related to patients' clinical prognosis is an important research topic nowadays.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	ShenYang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

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