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

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487340
• Other study ID #: CASE II
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: July 1, 2028

Study information

• Verified date: November 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD
• Phone: 13958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Acute stroke patients

Exclusion Criteria:

No

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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

Locations

Country	Name	City	State
China	Min Lou	Hangzhou	Zhejiang

Sponsors (7)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Huzhou Center Hospital, Jiaxing People's Hospital, Jinhua Center Hospital, Shaoxing People's Hospital, Taizhou Hospital, The Second Affiliated Hospital of Jiaxing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Independence (mRS 0-2) at 1 year		1 year
Secondary	All-cause mortality at 1 year		1 year
Secondary	Brain hemorrhage at 24-72 hours after hospitalization		72 hours
Secondary	The incidence of recurrent stroke or other vascular events at 1 year		1 year
Secondary	Independence (mRS 0-2) at 5 year		5 year
Secondary	The incidence of recurrent stroke or other vascular events at 5 year		5 year
Secondary	All-cause mortality at 5 year		5 year