STroke inpatient secOndary Prevention: current status and continuous care improvement

ISRCTN ISRCTN17207064
DOI https://doi.org/10.1186/ISRCTN17207064
Secondary identifying numbers 1
Submission date
30/03/2007
Registration date
26/04/2007
Last edited
22/09/2021
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 Wang Yongjun
Scientific

Beijing Tiantan Hospital
Tiantan Xili 6
Chongwen District
Beijing
100050
China

Email yongjunw@hotmail.com

Study information

Study designThe trial is a prospective cohort study. Because the staff take turns to care for the patients in different wards, it is impossible to randomise grouping.
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typePrevention
Scientific titleSTroke inpatient secOndary Prevention: current status and continuous care improvement
Study acronymSTOP
Study objectivesThe secondary prevention collaborative system is hospitalised; for doctors, it can increase the coincidence with the therapeutic regime and for patients, it can improve the compliance to the risk factor controls.
Ethics approval(s)Approval gained from the Beijing Tiantan Hospital Capital Medical University Ethics Board on the January 19, 2007.
Health condition(s) or problem(s) studiedIschaemic stroke and Transient Ischaemic Attack (TIA)
InterventionThe conception of this project is to organise the effective stroke secondary prevention program, which is initiated at hospitalisation, into the whole course of stroke care, thus improving the prophylaxis of inpatients with ischaemic stroke or TIA, on medical compliance, confidence, preventive efficacy.

There are three treatments:
1. The medical treatment includes drug treatments of hypertension, dyslipoidemia, carotid stenosis, and anti-platelet agents
2. The surgical treatment includes carotid endarterctomy, carotid angioplasty and stent
3. Lifestyle modifications comprise of stopping smoking, weight control and public education

The program is practiced on all patients who have a probability of scleratheromic stroke.
Intervention typeOther
Primary outcome measure1. The coincidence with the therapeutic regimen
2. The compliance to the risk factor controls
Secondary outcome measuresThe reoccurrence rate of vascular issues.
Overall study start date01/10/2006
Completion date01/06/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants1600
Key inclusion criteria1. Age equal to or older than 18 years
2. Ischaemic event (infarction/Transient Ischaemic Attack [TIA]) within two weeks
3. Diagnosis of infarction or TIA
Infarction:
a. sudden or rapid onset of focal ischaemic neurological impairments by all kinds of reasons
b. the impairments last more than 24 hours
TIA:
a. sudden or rapid onset of focal ischaemic neurological impairments by all kinds of reasons
b. the impairments are within 24 hours (the diagnosis could be made if the patient have one of the symptoms: amaurosis fugax, dysphasia, movement disorder such as weakness or clumsiness; but such symptoms as diplopia, scintillation, scotosis, vertigo, memory disorder and ataxia cannot support the diagnoses; the symptoms that may be caused by migraine are ruled out)
4. No matter which one it is, all have either a Computed Tomography (CT) or a Magnetic Resonance Imaging (MRI) scan, to preclude haemorrhage or other non-ischaemic nerve system diseases
5. All the diagnoses have been confirmed and registered by the research centre neurologist
6. Patient resident in Beijing for at least one year
7. Patient consents to follow up for at least one year
8. Mechanism of the event is probably infarction/TIA due to artery scleratheroma
9. More than one modifiable risk factors of Cardiovascular Disease (CVD)
10. The case collected in each research centre should be consecutive. Even the patients who qualified but reject to join in, should also be added in the sum and registered with the basic items such as name, sex, age
Key exclusion criteria1. Pregnancy
2. Silent infarction without symptoms or focal signs
3. Venous infarction
4. Other causes of ischaemic stroke but not scleratheromic. For example, cardiac resource, hyper-coagulation, dissection, vasculitis, medical resource such as the complications of carotid endarterctomy or angiography, traumatic resource, aura migraine, epilepsy, other non-ischaemic stroke
5. Reject to join in the study
6. Event episode concomitant with cardiac disease, cardiac insufficiency, hepatosis, renal inadequacy, respiratory failure, malignant tumour etc., and anticipate not to accomplish the one year-follow up
7. Glasgow Coma Score (GCS) less than four
Date of first enrolment01/10/2006
Date of final enrolment01/06/2008

Locations

Countries of recruitment

  • China

Study participating centre

Beijing Tiantan Hospital
Beijing
100050
China

Sponsor information

Beijing Tiantan Hospital (China)
Hospital/treatment centre

c/o Professor Wang Yongjun
Tiantan Xili 6
Chongwen District
Beijing
100050
China

Email yongjunw@hotmail.com
ROR logo "ROR" https://ror.org/003regz62

Funders

Funder type

Government

Beijing Municipal Science & Technology Commission (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

Editorial Notes

22/09/2021: Proactive update review. No publications found. Search options exhausted.