The Influence of day-to Day BPV on Long-term Adverse Outcomes in Patients Ischemic Stroke

NCT ID: NCT02663557

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-03-31

Brief Summary

Stroke is one of the most devastating disorder worldwide. Hypertension has been confirmed to be a major modifiable risk factor for stroke.Even the casual visit hypertension has been managed ideally,there is still surplus risk for stroke re-attack.The purpose of this study is to explore whether variation of 24-hour ambulatory and visit-to-visit blood pressure variability (BPV) contribute to recurrent stroke.

Detailed Description

System hypertension has been reported to play the most important role in the development of stroke,and the anti-hypertension therapy is regarded as the cornerstone for stroke secondary prevention. However, even though some proper measures have been taken,there is still surplus risk for recurrent stroke. Recently the variation of system blood pressure has been focused as the candidate of another risk factor.Up to date,this hypothesis remains an intense debate and few studies has been done to clarify it.Besides, the definition of BPV and measurement of BPV parameters are still beyond conformity.In the current study, the long-term and short-term BPV will be taken respectively for patients with prior stroke. Bsed on these parameters, the cohort will be followed up for average 2 years. The predefined outcome include composite cardiovascular events, neuropsychiatric wording, and mortality during followup.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

non-hypertension with lower BPV

patients meeting to flowing two criteria: 1. mean SBP\<140 mmHg; 2. Systolic blood pressure-coefficient variation (SBP-CV) \< Median SBP-CV

No interventions assigned to this group

non-hypertension with higher BPV

patients meeting to flowing two criteria: 1. mean SBP\< 140 mmHg; 2. SBP-CV \> Median SBP-CV

No interventions assigned to this group

hypertension with lower BPV

patients meeting to flowing two criteria: 1. mean SBP\> 140 mmHg; 2. SBP-CV \< Median SBP-CV

No interventions assigned to this group

hypertension with higher BPV

patients meeting to flowing two criteria: 1. mean SBP\> 140 mmHg; 2. SBP-CV \> Median SBP-CV

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

• comorbidity of dementia ( including AD, PDD, FTLD, VaD and so on )
• coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease that would influence mortality.
• discharge with severe sequelae with mRS>5

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhu Shi

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zhu Shi

deputy director of neurology department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhu Shi, MD,PhD

Role: STUDY_CHAIR

dongguan peoples' hospital

Locations

Dongguan Peoples' Hospital

Dongguan, Guangdong, China

Countries

China

Other Identifiers

2008105150027

Identifier Type: OTHER

Identifier Source: secondary_id

A2013836

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2008105150027

Identifier Type: -

Identifier Source: org_study_id