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

History of Changes

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 27, 2017

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