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

April 1, 2013 updated by: Guangzhou University of Traditional Chinese Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Brain Center,Guangdong Province Hospital of Traditional Chinese Medicine
        • Contact:
        • Sub-Investigator:
          • ZiYi Zhou, Master
        • Sub-Investigator:
          • Lin Wei, Master
        • Sub-Investigator:
          • XiaoPei Zhang, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ischemic Stroke or TIA (ISTIA) patients
Other: Hypertension Health Education Protocol (HHEP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
vascular death (death within 30 days after a vascular event) and all-cause mortality.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 1, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2013-036-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on To Investigate the Relationship Between the Adherence of HHEP After ISTIA and Stroke Recurrence or Cardiovascular Events.

Clinical Trials on Hypertension Health Education Protocol (HHEP)

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