Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
ACROSS-protocol 5
Study information
Scientific title
Abnormal gluCose Regulation in patients with acute strOke acroSS China: a national multicentre prospective study
Acronym
ACROSS-China
Study hypothesis
1. 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
Study design
Multicentre observational, prospective, cohort study
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Hospital
Study type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Abnormal glucose regulation, acute stroke
Intervention
All 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 type
Other
Primary outcome measure
The prevalence of abnormal glucose regulation after acute stroke in China, measured by OGTT before discharge.
Secondary outcome measures
1. 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 date
01/01/2008
Overall study end date
01/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Older than 18, either sex
2. Acute stroke: diagnosed on World Health Organization (WHO) criteria
3. Acute primary stroke patients within 14 days
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
4000
Participant exclusion criteria
1. 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
Recruitment start date
01/01/2008
Recruitment end date
01/09/2008
Locations
Countries of recruitment
China
Study participating centre
Beijing Tiantan Hospital
Beijing
100050
China
Sponsor information
Organisation
Bayer (China) Limited
Sponsor details
Corporate Communications
34/F Jing Guang Centre
Hu Jia Lou
Chaoyang District
Beijing
100020
China
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Bayer (China) Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
11th Five-year National Supporting Schedule of Science and Technology (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|