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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321225
• Other study ID #: BBBD-AIS
• Status: Recruiting
• Start date: March 10, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2022
• Source: Capital Medical University
• Contact: xunming ji, MD PhD
• Phone: 86-10-83198952
• Email: jixunming[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Diagnostic Test:
• the level of biomarker in bood
Elisa is used to test the level of biomarker in blood.

Locations

Country	Name	City	State
China	Xuanwu hospital;Capital Medical University	Beijin	XI Cheng District

Sponsors (1)

Lead Sponsor	Collaborator
Ji Xunming,MD,PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of serum biomarkers within 72h in ischemic stroke patients	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).	Day 0, Day 1, Day 2, Day 3.