To Investigate the Relationship Between the Adherence of HHEP After ISTIA and Stroke Recurrence or Cardiovascular Events. Clinical Trial
| NCT number | NCT01812421 |
| Other study ID # | B2013-036-01 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | March 14, 2013 |
| Last updated | April 1, 2013 |
| Start date | April 2013 |
Patients with a diagnosis of ischemic stroke or TIA (ISTIA), who are treated at hospital are
asked to participate in our pre specified hypertension health education protocol (HHEP)
after discharge from our hospital.HHEP was used as secondary prevention treatments of stroke
and cardiovascular diseases.
HHEP consists of several items such as controlling the patient's hypertension level,
monitoring the adherece of antihypertensive agents, reducing risk factors of hytertension
like tobacco smoking, obesity, and motivating the patient to physical activity and to a
healthy diet.
Patients will receive visits by a study nurse with the aim of supervising, monitoring, and
recording the adherence of HHEP. The patients will be classified as different adherence
level at the end of the study according to their adherence condition.
This study is aimed at testing the hypothesis that controlling hypertension and its risk
factors was more effective than those do not receive HHEP in reducing the recurrence of
stroke and cardiovascular diseases.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Participants were eligible for this observational cohort study if they were age 18 years or older; Hospitalized for a primary diagnosis of acute ischemic stroke or Transient Ischemic Attack (TIA) and concurrently diagnosed as hypertension; Provided consent to participate, and their data can be collected from Medical Record System of our hospital. Exclusion Criteria: We will exclude people who are onset of symptoms 3 months after their ischemic stroke or TIA; The stroke events occurred before the baseline survey were identified from the Hospital Discharge Register retrospectively and excluded from the analyses. |
Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| China | Brain Center,Guangdong Province Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Guangzhou University of Traditional Chinese Medicine |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Nonfatal vascular events: ischemic or hemorrhagic stroke recurrence (ICD-9 431 or ICD-10 I61), or myocardial infarction(MI) (ICD-9 410 or ICD-10 I21). | 1 year | No | |
| Secondary | vascular death (death within 30 days after a vascular event) and all-cause mortality. | 1 year | No |