NCT04487340

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2016Jul 2028

Study Start

First participant enrolled

January 1, 2016

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

11.5 years

First QC Date

July 19, 2020

Last Update Submit

November 21, 2022

Conditions

Stroke, Acute

Keywords

thrombolysisthrombectomyhospitalization

Outcome Measures

Primary Outcomes (1)

  • Independence (mRS 0-2) at 1 year

    1 year

Secondary Outcomes (6)

  • 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

    1 year

  • Independence (mRS 0-2) at 5 year

    5 year

  • The incidence of recurrent stroke or other vascular events at 5 year

    5 year

  • +1 more secondary outcomes

Interventions

EducationBEHAVIORAL

Provide each center with relevant education of guidelines, and help the clinicians to improve medical quality.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All acute stroke patients who were admitted to hospital.

You may qualify if:

  • Acute stroke patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Min Lou

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 38787930DERIVED

  • Xue R, Zhong W, Zhou Y, He Y, Yan S, Chen Z, Wang J, Gong X, Lou M. Endovascular Treatment for Minor Acute Ischemic Strokes With Large Vessel Occlusion. J Am Heart Assoc. 2022 Dec 20;11(24):e027326. doi: 10.1161/JAHA.122.027326. Epub 2022 Dec 19.

    PMID: 36533622DERIVED

  • Wang J, Zhang J, Gong X, Zhang W, Zhou Y, Lou M. Prediction of large vessel occlusion for ischaemic stroke by using the machine learning model random forests. Stroke Vasc Neurol. 2022 Apr;7(2):94-100. doi: 10.1136/svn-2021-001096. Epub 2021 Oct 26.

    PMID: 34702747DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Min Lou, PhD

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Min Lou, PhD

CONTACT

13958007213loumingxc@vip.sina.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 27, 2020

Study Start

January 1, 2016

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

November 23, 2022

Record last verified: 2022-11

Locations

CN(1)