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

The Level of Blood Brain Barrier Damage Biomarker Predicting Hemorrhagic Transformation Following Acute Ischemic Stroke

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05321225
Enrollment
1000
Registered
2022-04-11
Start date
2022-03-10
Completion date
2025-12-31
Last updated
2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

blood brain barrier, hemorrhagic transformation, ischemic stroke

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.

Interventions

Elisa is used to test the level of biomarker in blood.

Sponsors

Ji Xunming,MD,PhD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frameDescription
The change of serum biomarkers within 72h in ischemic stroke patientsDay 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).

Countries

China

Contacts

Primary Contactxunming ji, MD PhD
jixunming@vip.163.com86-10-83198952
Backup ContactZhifeng Qi, PhD
qizhifeng@xwh.ccmu.edu.cn86-10-83199236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026