Clinical trial NCT02675972: Which Parameters of Short-term Blood Pressure Variability Best Predict Early Outcomes in Acute Ischemic Stroke
Official title: Association of 24-hour Blood Pressure Variability With Early Outcomes in Patients With Acute Non Cardiogenic Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke, blood pressure, prognosis
Lead sponsor: Dongguan People's Hospital
Sponsor class: OTHER_GOV
First posted: 2016-02-05
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute ischemic stroke patients with 72 hour after onset

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke

Exclusion Criteria:

* 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 .

Primary outcomes:
measure: early neurological deterioration
timeFrame: 7 days after admission
Secondary outcomes:
measure: good functional outcome at 14 days
timeFrame: up to 14 days in-hospital
measure: good functional outcome at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan Peoples' Hospital
state: Guangdong
Study officials:
affiliation: dongguan peoples' hospital
name: zhu Shi, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.