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Blood Pressure Variability in Acute Ischemic Stroke (PREVISE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Nikolaos Kakaletsis, Aristotle University Of Thessaloniki.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01915862
First Posted: August 5, 2013
Last Update Posted: May 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
A & D Company Limited
Information provided by (Responsible Party):
Nikolaos Kakaletsis, Aristotle University Of Thessaloniki
August 1, 2013
August 5, 2013
May 19, 2015
August 2013
August 2016   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01915862 on ClinicalTrials.gov Archive Site
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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
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Unknown status
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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT01915862
AUTH-A7399-1862013
Yes
Not Provided
Not Provided
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