A Nested Case-control Study on the Secondary Prevention of Ischemic Stroke and TIA by Hypertension Health Education Protocol (HHEP): The Post-Stroke Preventive Trial

This study is currently recruiting participants.
Verified April 2013 by Guangzhou University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01812421
First received: March 14, 2013
Last updated: April 1, 2013
Last verified: April 2013

March 14, 2013
April 1, 2013
April 2013
April 2015   (final data collection date for primary outcome measure)
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). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01812421 on ClinicalTrials.gov Archive Site
vascular death (death within 30 days after a vascular event) and all-cause mortality. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
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A Nested Case-control Study on the Secondary Prevention of Ischemic Stroke and TIA by Hypertension Health Education Protocol (HHEP): The Post-Stroke Preventive Trial
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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.

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Interventional
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Masking: Open Label
Primary Purpose: Prevention
To Investigate the Relationship Between the Adherence of HHEP After ISTIA and Stroke Recurrence or Cardiovascular Events.
Other: Hypertension Health Education Protocol (HHEP)
Experimental: Ischemic Stroke or TIA (ISTIA) patients
Intervention: Other: Hypertension Health Education Protocol (HHEP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
April 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: YeFeng Cai, Dr. zizi_33@126.com
China
 
NCT01812421
B2013-036-01
Not Provided
Guangzhou University of Traditional Chinese Medicine
Guangzhou University of Traditional Chinese Medicine
Not Provided
Not Provided
Guangzhou University of Traditional Chinese Medicine
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP