Blood Pressure Variability in Acute Ischemic Stroke

Completed

• Conditions: Ischemic Stroke

• Registration Number: NCT01915862
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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.

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-05
• Primary Completion: 2018-05
• Study Completion: 2018-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale Score (mRS)	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)

Trial Locations

Locations (3)

Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina; 🇬🇷 Ioannina, Greece

First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece

Department of Medicine, Medical School, University of Thessaly, University Hospital of Larissa; 🇬🇷 Larissa, Greece