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OpenTrials
Completed

NCT Number: NCT01915862

Blood Pressure Variability in Acute Ischemic Stroke

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina, Ioannina, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • A & D Company Limited

Registry information

Official study title

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

Acronym: PREVISE

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2013
Registry last updated
May 20, 2024

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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