StrokeBPVNCT02675972
Which Parameters of Short-term Blood Pressure Variability Best Predict Early Outcomes in Acute Ischemic Stroke
An observational study of Stroke, run by Dongguan People's Hospital at 1 site in China.
Trial summary
Previous studies on the association between blood pressure variation (BPV) in acute ischemic stroke and functional outcomes yield conflicting result. The obscured definition and measurement of BPV engenders considerable confounding factors, making it difficult to interpret. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Apr 2016
- 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: acute ischemic stroke patients with 72 hour after onset
Who may be able to join
- acute ischemic stroke
Who cannot join
- cardiogenic cerebral embolisms due to atrial fibrillation, pronounced heart valve diseases or valve replacement operation;
- isolated sensory symptoms, isolated visual changes, isolated dizziness, or vertigo, without explicit MRI-DWI evidence for acute cerebral infarcts;
- coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease which would influence patients' independent functions .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of 24-hour Blood Pressure Variability With Early Outcomes in Patients With Acute Non Cardiogenic Ischemic Stroke
Previous studies on the association between blood pressure variation (BPV) in acute ischemic stroke and functional outcomes yield conflicting result. The obscured definition and measurement of BPV engenders considerable confounding factors, making it difficult to interpret. We aim to investigate the predictive role of 24-hour BPV on early outcomes in acute non-cardiogenic ischemic stroke.
Read the detailed description
This is a perspective registered cohort study. Patients with acute non-cardiogenic ischemic stroke are included into the study. During the first 24 hours after admission, the 24 hours blood pressure monitoring is to be taken and used to calculate various parameters of hour-to-hour blood pressure variability, including standard deviation(SD), coefficient of variation (CV), variation independent of mean(VIM) and average real variability (ARV) of systolic blood pressure (SBP) and diastolic blood pressure (DBP). The demographic and clinical data are also recorded. This is an observational sturdy, thus the caring physician make clinical decisions according to individual patient's condition. The endpoints are defined as early neurological deterioration, functional outcome(modified Rankin scale<3 as good outcome) at discharge and 3 months.
- 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 |
|---|---|---|
| patient with poor outcome | modified Rankin scale≥3 | |
| patients with favorable outcome | modified Rankin scale<3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
early neurological deterioration
NIHSS increase by 4 points or continuous consciousness deterioration
Measured: 7 days after admission
Secondary outcomes (2)
good functional outcome at 14 days
good functional outcomes as mRS≤2; poor outcome as mRS ≥3
Measured: up to 14 days in-hospital
good functional outcome at 3 months
good functional outcomes as mRS≤2; poor outcome as mRS ≥3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongguan People's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhu Shi, Dongguan People's Hospital
- Investigators
- zhu Shi, PhD,MD, Principal investigator, dongguan peoples' hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675972
- Sponsor's protocol ID
- DongguanPeoplesH
- Acronym
- BPV
- Status last verified
- May 2017
- First submitted
- 27 Jan 2016
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Under regulations of local ethic committee, data concerning individual privacy are not allowed to release.
Publications
Shi Z, Li ES, Zhong JS, Yuan JL, Li LR, Zheng CW. Predictive Significance of Day-to-Day Blood Pressure Variability in Acute Ischemic Stroke for 12-Month Functional Outcomes. Am J Hypertens. 2017 May 1;30(5):524-531. doi: 10.1093/ajh/hpx005.
PubMed 28203689
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of 24-hour Blood Pressure Variability With Early Outcomes in Patients With Acute Non Cardiogenic Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02675972
- Acronym / sponsor ID
- BPV / DongguanPeoplesH
- Conditions
- Stroke
- Keywords
- stroke, blood pressure, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Dongguan People's HospitalOther government
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 Feb 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.
Previous studies on the association between blood pressure variation (BPV) in acute ischemic stroke and functional outcomes yield conflicting result. The obscured definition and measurement of BPV engenders considerable confounding factors, making it difficult to interpret. We aim to investigate the predictive role of 24-hour BPV on early outcomes in acute non-cardiogenic ischemic stroke.
Detailed description
This is a perspective registered cohort study. Patients with acute non-cardiogenic ischemic stroke are included into the study. During the first 24 hours after admission, the 24 hours blood pressure monitoring is to be taken and used to calculate various parameters of hour-to-hour blood pressure variability, including standard deviation(SD), coefficient of variation (CV), variation independent of mean(VIM) and average real variability (ARV) of systolic blood pressure (SBP) and diastolic blood pressure (DBP). The demographic and clinical data are also recorded. This is an observational sturdy, thus the caring physician make clinical decisions according to individual patient's condition. The endpoints are defined as early neurological deterioration, functional outcome(modified Rankin scale<3 as good outcome) at discharge and 3 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with poor outcome | – | –modified Rankin scale≥3 |
| patients with favorable outcome | – | –modified Rankin scale<3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- acute ischemic stroke patients with 72 hour after onset
Key inclusion criteria (1 listed)
- acute ischemic stroke
Key exclusion criteria (3 listed)
- cardiogenic cerebral embolisms due to atrial fibrillation, pronounced heart valve diseases or valve replacement operation;
- isolated sensory symptoms, isolated visual changes, isolated dizziness, or vertigo, without explicit MRI-DWI evidence for acute cerebral infarcts;
- coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease which would influence patients' independent functions .
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
early neurological deterioration
Time frame: 7 days after admission
NIHSS increase by 4 points or continuous consciousness deterioration
2 secondary outcomes
good functional outcome at 14 days
Time frame: up to 14 days in-hospital
good functional outcome at 3 months
Time frame: 3 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 17 May 2017.
- Derived from this study: PubMed 28203689Shi Z, Li ES, Zhong JS, Yuan JL, Li LR, Zheng CW. Predictive Significance of Day-to-Day Blood Pressure Variability in Acute Ischemic Stroke for 12-Month Functional Outcomes. Am J Hypertens. 2017 May 1;30(5):524-531. doi: 10.1093/ajh/hpx005.
- Individual participant dataSharing planned: No. Under regulations of local ethic committee, data concerning individual privacy are not allowed to release.
Related trials for Stroke
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Symptomatic Carotid Outcomes Registry
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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
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The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
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A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
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Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
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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, PhD,MD principal investigator
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 Dongguan People's Hospital 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 17 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?
early neurological deterioration (time frame: 7 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675972, which also lists 1 linked publication.
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 17 May 2017.