The Level of Blood Brain Barrier Damage Biomarker in Acut... | NCT05321225

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

NCT05321225

Sponsor

Ji Xunming,MD,PhD

Status

Unknown status

Last Update Posted

Apr 15, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

the level of biomarker in bood

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2022Actual

Primary Completion Date

Mar 10, 2023Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 19, 2022

First Submission Date that Met QC Criteria

Apr 1, 2022

First Posted Date

Apr 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2022

Last Update Posted Date

Apr 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ji Xunming,MD,PhD, Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical UniversitySponsor-Investigator

Lead Sponsor

Ji Xunming,MD,PhDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
the level of biomarker in bood	Diagnostic Test	Elisa is used to test the level of biomarker in blood.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xunming ji, MD PhD	Contact	86-10-83198952		jixunming@vip.163.com
Zhifeng Qi, PhD	Contact	86-10-83199236		qizhifeng@xwh.ccmu.edu.cn

Overall Officials

Name	Affiliation	Role
Ke Jian Liu, PhD	Xuan Wu Hospital,Capital Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu hospital;Capital Medical University	Recruiting	Beijin	XI Cheng District	100053	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided