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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663557
• Other study ID #: 2008105150027
• Secondary ID: 2008105150027A20
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: May 18, 2017
• Start date: July 2014
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Dongguan People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
China	Dongguan Peoples' Hospital	Dongguan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhu Shi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	non-cardiovascular events	fall,frature and other unexpected adverse events	12 months
Primary	mortality	all cause death	12 months
Secondary	macrovascular events	stroke, including recurrent ischemic stroke and intra-cerebral hemorrhage, coronary artery events and peripheral artery occlusion	12 months
Secondary	microvascular events	cognition and psychological decline	12 months