Blood Pressure Variability in Acute Ischemic Stroke (PREVISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: April 3, 2014
Last verified: December 2013
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 300
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915862

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

No publications provided

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
Study First Received: August 1, 2013
Last Updated: April 3, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
Acute ischemic stroke
Blood pressure variability
Ambulatory arterial stiffness index
Ambulatory blood pressure monitoring
Outcome

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014