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Completed

NCT Number: NCT02675972

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongguan Peoples' Hospital

Dongguan, Guangdong, 523029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Primary outcomes

  1. early neurological deterioration

    Time frame: 7 days after admission

    NIHSS increase by 4 points or continuous consciousness deterioration

Secondary outcomes

  1. good functional outcome at 14 days

    Time frame: up to 14 days in-hospital

    good functional outcomes as mRS≤2; poor outcome as mRS ≥3

  2. good functional outcome at 3 months

    Time frame: 3 months

    good functional outcomes as mRS≤2; poor outcome as mRS ≥3

Sponsors and collaborators

Lead sponsor

Dongguan People's Hospital

Other Gov

Registry information

Official study title

Association of 24-hour Blood Pressure Variability With Early Outcomes in Patients With Acute Non Cardiogenic Ischemic Stroke

Acronym: BPV

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 5, 2016
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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