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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:
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
  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
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

Further study details as provided by Nikolaos Kakaletsis, Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 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)


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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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: May 18, 2015

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

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

ClinicalTrials.gov processed this record on July 21, 2017