Which Parameters of Short-term Blood Pressure Variability Best Predict Early Outcomes in Acute Ischemic Stroke

Completed

• Conditions: Stroke

• Registration Number: NCT02675972
• Lead Sponsor: Dongguan People's Hospital

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-05
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-05
• Study Completion: 2016-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
early neurological deterioration	7 days after admission	NIHSS increase by 4 points or continuous consciousness deterioration

Secondary Outcome Measures

Name	Time	Method
good functional outcome at 14 days	up to 14 days in-hospital	good functional outcomes as mRS≤2; poor outcome as mRS ≥3
good functional outcome at 3 months	3 months	good functional outcomes as mRS≤2; poor outcome as mRS ≥3

Trial Locations

Locations (1)

Dongguan Peoples' Hospital; 🇨🇳 Dongguan, Guangdong, China