NCT02663557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

January 21, 2016

Last Update Submit

May 18, 2017

Conditions

Keywords

stroke, blood pressure, prognosis

Outcome Measures

Primary Outcomes (1)

  • mortality

    all cause death

    12 months

Secondary Outcomes (2)

  • macrovascular events

    12 months

  • microvascular events

    12 months

Other Outcomes (1)

  • non-cardiovascular events

    12 months

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguan Peoples' Hospital

Dongguan, Guangdong, 523029, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zhu Shi, MD,PhD

    dongguan peoples' hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
deputy director of neurology department

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 26, 2016

Study Start

July 1, 2014

Primary Completion

June 1, 2016

Study Completion

March 1, 2017

Last Updated

May 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

The data will not be shared with respect to the privacy of patients info.

Locations