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

April 10, 2022 updated by: Ji Xunming,MD,PhD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • XI Cheng District
      • Beijin, XI Cheng District, China, 100053
        • Recruiting
        • Xuanwu hospital;Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute ischemic stroke patients received standard therapy within 24-hour since stroke onset

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of serum biomarkers within 72h in ischemic stroke patients
Time Frame: 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).
Day 0, Day 1, Day 2, Day 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ji Xunming,MD,PhD

Investigators

  • Principal Investigator: Ke Jian Liu, PhD, Xuan Wu Hospital，Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Anticipated)

March 10, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 19, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 10, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBBD-AIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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