ISRCTN ISRCTN69559777
DOI https://doi.org/10.1186/ISRCTN69559777
Secondary identifying numbers ACROSS-protocol 5
Submission date
05/01/2008
Registration date
29/05/2008
Last edited
29/05/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Yongjun Wang
Scientific

Beijing Tiantan Hospital
Tiantan Xili 6
Chongwen District
Beijing
100050
China

Study information

Study designMulticentre observational, prospective, cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleAbnormal gluCose Regulation in patients with acute strOke acroSS China: a national multicentre prospective study
Study acronymACROSS-China
Study objectives1. The prevalence of abnormal glucose regulation in patients with acute stroke is high
2. The distribution of stroke subtypes is different in the subtypes of the abnormal glucose regulation
3. Patients with or without abnormal glucose regulation will have different outcomes and recurrent risk of stroke
4. Different subtypes of abnormal glucose regulation have different effects on the outcomes and recurrence of stroke
Ethics approval(s)Ethics approval received from the Tiantan Hospital Ethics Committee on the 28th August 2007
Health condition(s) or problem(s) studiedAbnormal glucose regulation, acute stroke
InterventionAll participants without a history of diabetes mellitus will be identified as having abnormal glucose regulation or not by using the oral glucose tolerance test (OGTT) three days before discharge. The outcome and recurrence of stroke will be compared between the patients with and without abnormal glucose regulation respectively at three months and one year after the onset of stroke as below:
1. Modified Rankin Scale (mRS)
2. The times of stroke recurrence

The current therapy measures of abnormal glucose regulation in patients with acute stroke will be observed during in-hospital and follow-up.
Intervention typeOther
Primary outcome measureThe prevalence of abnormal glucose regulation after acute stroke in China, measured by OGTT before discharge.
Secondary outcome measures1. The distribution of stroke subtypes is different in the subtypes of the abnormal glucose regulation
2. The outcome and recurrence risk of stroke in patients with or without abnormal glucose regulation
Overall study start date01/01/2008
Completion date01/09/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants4000
Key inclusion criteria1. Older than 18, either sex
2. Acute stroke: diagnosed on World Health Organization (WHO) criteria
3. Acute primary stroke patients within 14 days
Key exclusion criteria1. Cerebral infarction without symptoms and signs
2. Non-cerebrovascular events
3. Stroke patients out of 14 days
4. Without the content of patients or their legal agents
Date of first enrolment01/01/2008
Date of final enrolment01/09/2008

Locations

Countries of recruitment

  • China

Study participating centre

Beijing Tiantan Hospital
Beijing
100050
China

Sponsor information

Bayer (China) Limited
Industry

Corporate Communications
34/F Jing Guang Centre
Hu Jia Lou, Chaoyang District
Beijing
100020
China

Website http://www.bayerchina.com.cn
ROR logo "ROR" https://ror.org/05d5yxq17

Funders

Funder type

Industry

Bayer (China) Limited

No information available

11th Five-year National Supporting Schedule of Science and Technology (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan