Blood Pressure Variability in Acute Ischemic Stroke (PREVISE)
|ClinicalTrials.gov Identifier: NCT01915862|
Recruitment Status : Unknown
Verified May 2015 by Nikolaos Kakaletsis, Aristotle University Of Thessaloniki.
Recruitment status was: Recruiting
First Posted : August 5, 2013
Last Update Posted : May 19, 2015
|Condition or disease|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|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|
- Modified Rankin Scale Score (mRS) [ Time Frame: Three months (90 days) ]
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915862
|Contact: Nikolaos Kakaletsis, MD, MScfirstname.lastname@example.org|
|Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina||Recruiting|
|Ioannina, Greece, 45110|
|Contact: Haralambos Milionis, MD, PhD email@example.com|
|Department of Medicine, Medical School, University of Thessaly, University Hospital of Larissa||Recruiting|
|Larissa, Greece, 41110|
|Contact: George Ntaios, MD, MSc, PhD firstname.lastname@example.org|
|First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital||Recruiting|
|Thessaloniki, Greece, 54636|
|Contact: Nikolaos Kakaletsis, MD, MSc email@example.com|
|Study Director:||Apostolos I. Hatzitolios, MD, PhD||Aristotle University of Thessaloniki, AHEPA University Hospital|