StrokeNCT02663557
The Influence of day-to Day BPV on Long-term Adverse Outcomes in Patients Ischemic Stroke
An observational study of Stroke, run by Zhu Shi at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute ischemic stroke, which should be verified by define radiological evidences and acute onset of clinical manifestations.
Who may be able to join
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Keywords
- stroke, blood pressure, prognosis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
mortality
all cause death
Measured: 12 months
Secondary outcomes (2)
macrovascular events
stroke, including recurrent ischemic stroke and intra-cerebral hemorrhage, coronary artery events and peripheral artery occlusion
Measured: 12 months
microvascular events
cognition and psychological decline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhu Shi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zhu Shi, Dongguan People's Hospital
- Investigators
- Zhu Shi, MD,PhD, Study chair, dongguan peoples' hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663557
- Sponsor's protocol ID
- 2008105150027
- Other IDs
- 2008105150027, A2013836
- Status last verified
- May 2017
- First submitted
- 21 Jan 2016
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The data will not be shared with respect to the privacy of patients info.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02663557
- Acronym / sponsor ID
- 2008105150027
- Conditions
- Stroke
- Keywords
- stroke, blood pressure, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Zhu ShiOther government
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute ischemic stroke, which should be verified by define radiological evidences and acute onset of clinical manifestations.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: 12 months
all cause death
2 secondary outcomes
macrovascular events
Time frame: 12 months
microvascular events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Individual participant dataSharing planned: No. The data will not be shared with respect to the privacy of patients info.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhu Shi, MD,PhD study chair
dongguan peoples' hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Zhu Shi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.