Blood Pressure Variability in Acute Ischemic Stroke (PREVISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Aristotle University Of Thessaloniki
Sponsor:
Collaborator:
A & D Company Limited
Information provided by (Responsible Party):
Nikolaos Kakaletsis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01915862
First received: August 1, 2013
Last updated: May 18, 2015
Last verified: May 2015

August 1, 2013
May 18, 2015
August 2013
August 2016   (final data collection date for primary outcome measure)
Modified Rankin Scale Score (mRS) [ Time Frame: Three months (90 days) ] [ Designated as safety issue: No ]

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)
Same as current
Complete list of historical versions of study NCT01915862 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Blood Pressure Variability in Acute Ischemic Stroke
Comparison of Blood Pressure Variability Indices and Ambulatory Arterial Stiffness Index as Prognostic Indicators in the Medium Term Outcome of 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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
3 Months
Not Provided
Non-Probability Sample

All consecutive patients admitted to Departments of Medicine of three University Hospitals (Thessaloniki, Larissa, Ioannina) with the diagnosis of acute ischemic stroke

Ischemic Stroke
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
August 2016
August 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Nikolaos Kakaletsis, MD, MSc 00306976692724 kakaletsisnikos@yahoo.gr
Greece
 
NCT01915862
AUTH-A7399-1862013
Yes
Nikolaos Kakaletsis, Aristotle University Of Thessaloniki
Aristotle University Of Thessaloniki
A & D Company Limited
Study Director: Apostolos I. Hatzitolios, MD, PhD Aristotle University of Thessaloniki, AHEPA University Hospital
Aristotle University Of Thessaloniki
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP