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

Evaluating the Influence of Day-to-day Blood Pressure Variation in Acute Ischemic Stroke on Adverse Outcomes in Long-term Post-stroke Followup

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523029
      • Dongguan peoples' hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with acute ischemic stroke, which should be verified by define radiological evidences and acute onset of clinical manifestations.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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
non-hypertension with higher BPV; patients meeting to flowing two criteria: 1. mean SBP< 140 mmHg; 2. SBP-CV > Median SBP-CV
hypertension with lower BPV; patients meeting to flowing two criteria: 1. mean SBP> 140 mmHg; 2. SBP-CV < Median SBP-CV
hypertension with higher BPV; patients meeting to flowing two criteria: 1. mean SBP> 140 mmHg; 2. SBP-CV > Median SBP-CV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	all cause death	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
macrovascular events	stroke, including recurrent ischemic stroke and intra-cerebral hemorrhage, coronary artery events and peripheral artery occlusion	12 months
microvascular events	cognition and psychological decline	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-cardiovascular events	fall,frature and other unexpected adverse events	12 months

Collaborators and Investigators

• Sponsor: Zhu Shi
• Investigators: Study Chair: Zhu Shi, MD,PhD, Dongguan peoples' hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: stroke, blood pressure, prognosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2008105150027 (Other Identifier: dongguan sci and tech bureau); A2013836 (Other Grant/Funding Number: guangdong province medical science and research fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will not be shared with respect to the privacy of patients info.