Blood Pressure Variability in Acute Ischemic Stroke (PREVISE)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	300 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
Estimated Primary Completion Date :	August 2016
Estimated Study Completion Date :	August 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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)

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Nikolaos Kakaletsis, MD, MSc	00306976692724	kakaletsisnikos@yahoo.gr

Locations

Greece
Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina	Recruiting
Ioannina, Greece, 45110
Contact: Haralambos Milionis, MD, PhD hmilioni@uoi.gr
Department of Medicine, Medical School, University of Thessaly, University Hospital of Larissa	Recruiting
Larissa, Greece, 41110
Contact: George Ntaios, MD, MSc, PhD gntaios@med.uth.gr
First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital	Recruiting
Thessaloniki, Greece, 54636
Contact: Nikolaos Kakaletsis, MD, MSc kakaletsisnikos@yahoo.gr

Sponsors and Collaborators

Aristotle University Of Thessaloniki

A & D Company Limited

Investigators

Study Director:	Apostolos I. Hatzitolios, MD, PhD	Aristotle University of Thessaloniki, AHEPA University Hospital

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	May 19, 2015
Last Verified:	May 2015

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:

Stroke; Ischemia; Cerebral Infarction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia