The Level of Blood Brain Barrier Damage Biomarker in Acute Ischemic Stroke

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT05321225
• Lead Sponsor: Ji Xunming,MD,PhD

Brief Summary

Hemorrhagic transformation is a common complication of acute ischemic stroke patients . BBB damage is regarded as a major pathophysiological mechanism of hemorrhagic transformation. So, the investigators hypothesis the level of BBB damage biomarker is predictor of intracranial hemorrhage following ischemic stroke.

Detailed Description

Hemorrhagic transformation is a common complication of acute ischemic stroke patients . BBB injury often occurs in the early stage of ischemic stroke, leading brain tissue edema or even hemorrhagic transformation with the development of ischemic injury. The biomarker of BBB damage, such as the level of serum occludin, can reflect the extent of BBB injury. So, the investigators hypothesis the level of BBB damage biomarker is predictor of intracranial hemorrhage following ischemic stroke.

Study Timeline

• Study Start: 2022-03-10
• Study First Submitted: 2022-03-19
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-01
• Last Update Submitted: 2022-04-10
• Study First Posted: 2022-04-11
• Last Update Posted: 2022-04-15
• Primary Completion: 2023-03-10
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Enrolled patients aged 18-80years.
2. Acute ischemic stroke
3. Informed consent obtained.

Exclusion Criteria

1. Tumor stroke or hemorrhagic stroke or hemorrhagic cerebral infarction on admission.
2. Stroke or serious head trauma within the previous 3 months
3. inflammatory or infectious diseases, cancer, coagulation disturbance disease and severe renal and liver failure
4. blood sample occurred hemolysis or cloudy.
5. Incomplete clinical data
6. Platelet count of less than 100,000 per cubic millimeter
7. Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
8. Pregnant or breast-feeding women
9. Patients being enrolled or having been enrolled in other clinical trial -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of serum biomarkers within 72h in ischemic stroke patients	Day 0, Day 1, Day 2, Day 3.	The level of biomarkers are detected using Elisa(Enzyme Linked Immunosorbent Assay)，biomarkers including Occludin(ng/mL), Claudin-5(ng/mL), MMP-2/9(ng/mL)，c-Fn(ug/mL), ZO-1(pg/mL), vWF(ng/mL), IL-2RA(ng/mL), CCL16(ng/mL), CNTN(ng/mL), SELE(ng/mL) and PGLYRP1(ng/mL).

Trial Locations

Locations (1)

Xuanwu hospital;Capital Medical University; 🇨🇳 Beijin, XI Cheng District, China