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Clinical Trials/NCT01915862
NCT01915862
Completed
Not Applicable

Comparison of Blood Pressure Variability Indices and Ambulatory Arterial Stiffness Index as Prognostic Indicators in the Medium Term Outcome of Acute Ischemic Stroke

Aristotle University Of Thessaloniki3 sites in 1 country353 target enrollmentAugust 2013
ConditionsIschemic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
Aristotle University Of Thessaloniki
Enrollment
353
Locations
3
Primary Endpoint
Modified Rankin Scale Score (mRS)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is the evaluation and comparison of blood pressure variability indices and ambulatory arterial stiffness index obtained by ambulatory blood pressure monitoring as prognostic indicators in the functional outcome of acute ischemic stroke.

Detailed Description

All consecutive patients admitted with acute (within 24 hours after stroke onset) ischemic stroke in three University Hospital of Northern and Central Greece will be included. Blood pressure measurements are being obtained with ambulatory 24-hour BP monitoring (ABPM) every 20 minutes within 24 hours of admission using automated oscillometric device (TM2430, A\&D Company Ltd) during day-time (7:00-22:59) and night-time (23:00-6:59). Several clinical, laboratory and imaging parameters are prospectively registered. Also, patients' medical history, previous medical treatment and cardiovascular risk factors are registered. Functional outcome is assessed by the modified Rankin Scale score at 3 months. Also, stroke recurrence and cardiovascular and all-cause mortality will be assessed.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
December 2018
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nikolaos Kakaletsis

MD, MSc, Resident in Internal Medicine, AHEPA University Hospital

Aristotle University Of Thessaloniki

Eligibility Criteria

Inclusion Criteria

  • Acute ischemic stroke
  • Admission within 24 after the onset of symptoms

Exclusion Criteria

  • Transient ischemic attack
  • Intracerebral hemorrhage
  • Subarachnoid hemorrhage
  • Cerebral sinus venous thrombosis
  • Stroke mimics
  • Late admission (\>24 hours after stroke onset)

Outcomes

Primary Outcomes

Modified Rankin Scale Score (mRS)

Time Frame: Three months (90 days)

Description (score) * No symptoms at all (0) * No significant disability despite symptoms; able to carry out all usual duties and activities (1) * Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance (2) * Moderate disability; requiring some help, but able to walk without assistance (3) * Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance (4) * Severe disability; bedridden, incontinent and requiring constant nursing care and attention(5) * Dead (6)

Study Sites (3)

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