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Blood Pressure Variability in Acute Ischemic Stroke (PREVISE)

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ClinicalTrials.gov Identifier: NCT01915862
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
A & D Company Limited
Information provided by (Responsible Party):
Nikolaos Kakaletsis, Aristotle University Of Thessaloniki

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.

Condition or disease
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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 353 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Comparison of Blood Pressure Variability Indices and Ambulatory Arterial Stiffness Index as Prognostic Indicators in the Medium Term Outcome of Acute Ischemic Stroke
Study Start Date : August 2013
Actual Primary Completion Date : May 2018
Actual Study Completion Date : December 2018



Primary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients admitted to Departments of Medicine of three University Hospitals (Thessaloniki, Larissa, Ioannina) with the diagnosis of acute ischemic stroke
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915862


Locations
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Greece
Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina
Ioannina, Greece, 45110
Department of Medicine, Medical School, University of Thessaly, University Hospital of Larissa
Larissa, Greece, 41110
First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital
Thessaloniki, Greece, 54636
Sponsors and Collaborators
Aristotle University Of Thessaloniki
A & D Company Limited
Investigators
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Study Director: Apostolos I. Hatzitolios, MD, PhD Aristotle University of Thessaloniki, AHEPA University Hospital

Additional Information:

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Responsible Party: Nikolaos Kakaletsis, MD, MSc, Resident in Internal Medicine, AHEPA University Hospital, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01915862     History of Changes
Other Study ID Numbers: AUTH-A7399-1862013
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Keywords provided by Nikolaos Kakaletsis, Aristotle University Of Thessaloniki:
Acute ischemic stroke
Blood pressure variability
Ambulatory arterial stiffness index
Ambulatory blood pressure monitoring
Outcome
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia