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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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Hypertension Health Education Protocol (HHEP)

About this trial

This is an interventional prevention trial for To Investigate the Relationship Between the Adherence of HHEP After ISTIA and Stroke Recurrence or Cardiovascular Events.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Brain Center,Guangdong Province Hospital of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ischemic Stroke or TIA (ISTIA) patients

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

vascular death (death within 30 days after a vascular event) and all-cause mortality.

Full Information

NCT ID

NCT01812421

First Posted

March 14, 2013

Last Updated

April 1, 2013

Sponsor

Guangzhou University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01812421

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangzhou University of Traditional Chinese Medicine

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Masking

None (Open Label)

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ischemic Stroke or TIA (ISTIA) patients

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Hypertension Health Education Protocol (HHEP)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

vascular death (death within 30 days after a vascular event) and all-cause mortality.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

YeFeng Cai, Dr.

zizi_33@126.com

Facility Information:

Facility Name

Brain Center,Guangdong Province Hospital of Traditional Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

YeFeng Cai, Dr.

zizi_33@126.com

First Name & Middle Initial & Last Name & Degree

ZiYi Zhou, Master

First Name & Middle Initial & Last Name & Degree

Lin Wei, Master

First Name & Middle Initial & Last Name & Degree

XiaoPei Zhang, Master

12. IPD Sharing Statement

Learn more about this trial

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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