Condition category
Circulatory System
Date applied
05/01/2008
Date assigned
29/05/2008
Last edited
29/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yongjun Wang

ORCID ID

Contact details

Beijing Tiantan Hospital
Tiantan Xili 6
Chongwen District
Beijing
100050
China

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

01/09/2008

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.bayerchina.com.cn

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes