STroke inpatient secOndary Prevention: current status and continuous care improvement
| ISRCTN | ISRCTN17207064 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17207064 |
| Protocol serial number | 1 |
| Sponsor | Beijing Tiantan Hospital (China) |
| Funder | Beijing Municipal Science & Technology Commission (China) |
- 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
Scientific
Beijing Tiantan Hospital
Tiantan Xili 6
Chongwen District
Beijing
100050
China
| yongjunw@hotmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | The 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. |
| Secondary study design | Cohort study |
| Scientific title | STroke inpatient secOndary Prevention: current status and continuous care improvement |
| Study acronym | STOP |
| Study objectives | The 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) studied | Ischaemic stroke and Transient Ischaemic Attack (TIA) |
| Intervention | The 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 type | Other |
| Primary outcome measure(s) |
1. The coincidence with the therapeutic regimen |
| Key secondary outcome measure(s) |
The reoccurrence rate of vascular issues. |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 1600 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/10/2006 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing Tiantan Hospital
Beijing
100050
China
100050
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
22/09/2021: Proactive update review. No publications found. Search options exhausted.