Thrombus Analysis of Ischemic Stroke | NCT07043413

Studies
Thrombus Analysis of Ischemic Stroke

NCT07043413

Sponsor

Seoul National University Hospital

Status

Recruiting

Last Update Posted

Jun 29, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cerebral Infarction

Interventions

thrombus analysis

Countries

South Korea

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

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2022Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Jun 20, 2025

First Submission Date that Met QC Criteria

Jun 20, 2025

First Posted Date

Jun 29, 2025Actual

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

Jun 20, 2025

Last Update Posted Date

Jun 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Patients with acute ischemic stroke who have undergone endovascular thrombectomy will be eligible to be included, and thrombus will be collected after obtaining informed consent. Enrolled patients will receive a comprehensive diagnostic evaluation and the best medical treatment according to recent stroke management guidelines. The mechanism of the stroke will be classified into atherosclerotic, cardiac embolism, others and unknown causes based on diagnostic workup. Patients will be monitored in an outpatient clinic for vascular events including stroke recurrence, death, and bleeding events, which will continue for up to two years after the initial stroke event. Thrombus information related to RNA expression patterns and histological characteristics will be analyzed to classify the stroke mechanism and predict future vascular events after the initial stroke.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
thrombus analysis	Diagnostic Test	Detailed expression pattern of RNA and histological characteristics will be investigated.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vascular events	major vascular events after endovascular thrombectomy, including stroke, myocardial infarction, and vascular death	two years after initial stroke

Secondary Outcomes

Measure	Description	Time Frame
Thromboembolic events	Any thromboembolic events after endovascular thrombectomy including ischemic stroke, transient ischemic attack, myocardial infarction or unstable angina, peripheral artery disease requiring hospitalization, venous thromboembolism, pulmonary embolism and vascular death	two years after initial stroke

Other Outcomes

Measure	Description	Time Frame
overall mortality	any death event after endovascular thrombectomy	two years after initial stroke

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with acute ischemic stroke who had undergone endovascular thrombectomy

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with acute ischemic stroke who had undergone endovascular thrombectomy and agreed to participate to the study

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul	Jong-ro Gu	03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002544	Cerebral Infarction
D013927	Thrombosis

Ancestor Terms

ID	Term
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided