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

Stroke Clinical Trial

— BPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675972
• Other study ID #: DongguanPeoplesH
• Status: Completed
• Phase: N/A
• First received: January 27, 2016
• Last updated: May 15, 2017
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2017
• Source: Dongguan People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. We aim to investigate the predictive role of 24-hour BPV on early outcomes in acute non-cardiogenic ischemic stroke.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
China	Dongguan Peoples' Hospital	Dongguan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Dongguan People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early neurological deterioration	NIHSS increase by 4 points or continuous consciousness deterioration	7 days after admission
Secondary	good functional outcome at 14 days	good functional outcomes as mRS=2; poor outcome as mRS =3	up to 14 days in-hospital
Secondary	good functional outcome at 3 months	good functional outcomes as mRS=2; poor outcome as mRS =3	3 months