Blood Pressure Variability in Acute Ischemic Stroke

NCT ID: NCT01915862

Last Updated: 2024-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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A & D Company Limited

INDUSTRY

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Nikolaos Kakaletsis

MD, MSc, Resident in Internal Medicine, AHEPA University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Apostolos I. Hatzitolios, MD, PhD

Role: STUDY_DIRECTOR

Aristotle University of Thessaloniki, AHEPA University Hospital

Locations

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Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina

Ioannina, , Greece

Site Status

Department of Medicine, Medical School, University of Thessaly, University Hospital of Larissa

Larissa, , Greece

Site Status

First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 26283262 (View on PubMed)

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.

Reference Type RESULT
PMID: 35666577 (View on PubMed)

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.

Reference Type RESULT
PMID: 36583356 (View on PubMed)

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.

Reference Type RESULT
PMID: 37510931 (View on PubMed)

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.

Reference Type RESULT
PMID: 38754240 (View on PubMed)

Other Identifiers

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AUTH-A7399-1862013

Identifier Type: -

Identifier Source: org_study_id

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