Clinical trial NCT01915862: Blood Pressure Variability in Acute Ischemic Stroke
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: Acute ischemic stroke
Blood pressure variability
Ambulatory arterial stiffness index
Ambulatory blood pressure monitoring
Outcome
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: A & D Company Limited
First posted: 2013-08-05
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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)

Primary outcomes:
measure: Modified Rankin Scale Score (mRS)
timeFrame: Three months (90 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina
city: Larissa
country: Greece
facility: Department of Medicine, Medical School, University of Thessaly, University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital
Study officials:
affiliation: Aristotle University of Thessaloniki, AHEPA University Hospital
name: Apostolos I. Hatzitolios, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kakaletsis N, Ntaios G, Milionis H, Haidich AB, Makaritsis K, Savopoulos C, Berge E, Hatzitolios AI. Prognostic value of 24-h ABPM in acute ischemic stroke for short-, medium-, and long-term outcome: a systematic review and meta-analysis. Int J Stroke. 2015 Oct;10(7):1000-7. doi: 10.1111/ijs.12609. Epub 2015 Aug 18.
citation: Kakaletsis N, Ntaios G, Milionis H, Karagiannaki A, Chouvarda I, Dourliou V, Chytas A, Hatzitolios AI, Savopoulos C. Prognostic significance of 24-h blood pressure and variability indices in the outcome of acute ischaemic stroke. Intern Med J. 2023 Jul;53(7):1137-1146. doi: 10.1111/imj.15834. Epub 2022 Sep 12.
citation: Kakaletsis N, Ntaios G, Milionis H, Protogerou AD, Karagiannaki A, Chouvarda I, Dourliou V, Ladakis I, Kaiafa G, Daios S, Doumas M, Savopoulos C. Time of blood pressure in target range in acute ischemic stroke. J Hypertens. 2023 Feb 1;41(2):303-309. doi: 10.1097/HJH.0000000000003331. Epub 2022 Nov 25.
citation: Kakaletsis N, Ntaios G, Milionis H, Karagiannaki A, Chouvarda I, Dourliou V, Ladakis I, Kaiafa G, Vemmos K, Savopoulos C. Midday Dipping and Circadian Blood Pressure Patterns in Acute Ischemic Stroke. J Clin Med. 2023 Jul 21;12(14):4816. doi: 10.3390/jcm12144816.
citation: Karagiannaki A, Kakaletsis N, Chouvarda I, Dourliou V, Milionis H, Savopoulos C, Ntaios G. Association between antihypertensive treatment, blood pressure variability, and stroke severity and outcomes in acute ischemic stroke. J Clin Neurosci. 2024 Jul;125:51-58. doi: 10.1016/j.jocn.2024.05.014. Epub 2024 May 15.