Blood Pressure Variability in Acute Ischemic Stroke (PREVISE)
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.
|Study Type:||Observational [Patient Registry]|
|Study Design:||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|
- Modified Rankin Scale Score (mRS) [ Time Frame: Three months (90 days) ] [ Designated as safety issue: No ]
- 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 Start Date:||August 2013|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915862
|Contact: Nikolaos Kakaletsis, MD, MScemail@example.com|
|Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina||Recruiting|
|Ioannina, Greece, 45110|
|Contact: Haralambos Milionis, MD, PhD firstname.lastname@example.org|
|Department of Medicine, Medical School, University of Thessaly, University Hospital of Larissa||Recruiting|
|Larissa, Greece, 41110|
|Contact: George Ntaios, MD, MSc, PhD email@example.com|
|First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital||Recruiting|
|Thessaloniki, Greece, 54636|
|Contact: Nikolaos Kakaletsis, MD, MSc firstname.lastname@example.org|
|Study Director:||Apostolos I. Hatzitolios, MD, PhD||Aristotle University of Thessaloniki, AHEPA University Hospital|