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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 260

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523029
      • Dongguan peoples' hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

acute ischemic stroke patients with 72 hour after onset

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patient with poor outcome; modified Rankin scale≥3
patients with favorable outcome; modified Rankin scale<3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early neurological deterioration	NIHSS increase by 4 points or continuous consciousness deterioration	7 days after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
good functional outcome at 14 days	good functional outcomes as mRS≤2; poor outcome as mRS ≥3	up to 14 days in-hospital
good functional outcome at 3 months	good functional outcomes as mRS≤2; poor outcome as mRS ≥3	3 months

Collaborators and Investigators

• Sponsor: Dongguan People's Hospital
• Investigators: Principal Investigator: zhu Shi, PhD,MD, Dongguan peoples' hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: stroke, blood pressure, prognosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: DongguanPeoplesH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Under regulations of local ethic committee, data concerning individual privacy are not allowed to release.

Study Data/Documents

1. Clinical Study Report