Computer-based Online Database of Acute Stroke Patients f... | NCT04487340

Studies
Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation

NCT04487340

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Nov 23, 2022Actual

Enrollment

200,000Estimated

Phase

Not provided

Conditions

Stroke, Acute

Interventions

Education

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

Nov 2022

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 1, 2016Actual

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Jul 1, 2028Estimated

First Submitted Date

Jul 19, 2020

First Submission Date that Met QC Criteria

Jul 24, 2020

First Posted Date

Jul 27, 2020Actual

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

Nov 21, 2022

Last Update Posted Date

Nov 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Name	Class
Shaoxing People's Hospital	OTHER
Affiliated Hospital of Jiaxing University	OTHER
Huzhou Center Hospital	OTHER
The Second Affiliated Hospital of Jiaxing University

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

In the past three decades, the burden of stroke has increased in China and has gradually become the leading cause of death. The data acquisition and medical quality management still need to be improved in China. The purpose of this study was to establish online database of acute stroke patients for stroke management quality evaluation in China.

Detailed Description

This study is a prospective multi-center registration study. The data of acute ischemic stroke patients who underwent reperfusion therapy were registered on emergency platform. The data of stroke patients who were hospitalized were registered on stroke meidical quality control platform. The information including demographics, risk factors (history of hypertension, diabetes, stroke/TIA or atrial fibrillation, etc), prior antiplatelet usage, onset to door time (ODT), baseline National Institutes of Health Stroke Scale (NIHSS) score, baseline infarct core volume, laboratory data, ect were recorded. Clinical outcome at 3 months and 1 year was assessed.

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

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education	Behavioral	Provide each center with relevant education of guidelines, and help the clinicians to improve medical quality.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Independence (mRS 0-2) at 1 year		1 year

Secondary Outcomes

Measure	Description	Time Frame
All-cause mortality at 1 year		1 year
Brain hemorrhage at 24-72 hours after hospitalization		72 hours
The incidence of recurrent stroke or other vascular events at 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute stroke patients

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

All acute stroke patients who were admitted to hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Lou, PhD	Contact	13958007213		loumingxc@vip.sina.com

Overall Officials

Name	Affiliation	Role
Min Lou, PhD	Second Affiliated Hospital, School of Medicine, Zhejiang University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Min Lou	Recruiting	Hangzhou	Zhejiang	310000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38787930	Derived	Zhou H, Zhong W, Zhang T, Xu C, Zhong G, Xie G, Zhang B, Chen H, Wang E, Xu D, Cheng C, Yang J, Lou M, Yan S; CASE-II Study Group. Comparing Outcomes of Thrombectomy Versus Intravenous Thrombolysis Based on Middle Cerebral Artery M2 Occlusion Features. Stroke. 2024 Jun;55(6):1592-1600. doi: 10.1161/STROKEAHA.123.044986. Epub 2024 May 24.
36533622

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics