NCT01915862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

4.8 years

First QC Date

August 1, 2013

Last Update Submit

May 17, 2024

Conditions

Keywords

Acute ischemic strokeBlood pressure variabilityAmbulatory arterial stiffness indexAmbulatory blood pressure monitoringOutcome

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale Score (mRS)

    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)

    Three months (90 days)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Acute ischemic stroke
  • Admission within 24 after the onset of symptoms

You may not qualify if:

  • Transient ischemic attack
  • Intracerebral hemorrhage
  • Subarachnoid hemorrhage
  • Cerebral sinus venous thrombosis
  • Stroke mimics
  • Late admission (\>24 hours after stroke onset)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Ioannina, 45110, Greece

Location

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

Larissa, 41110, Greece

Location

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

Thessaloniki, 54636, Greece

Location

Related Publications (5)

  • 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.

    PMID: 26283262BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Apostolos I. Hatzitolios, MD, PhD

    Aristotle University of Thessaloniki, AHEPA University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, Resident in Internal Medicine, AHEPA University Hospital

Study Record Dates

First Submitted

August 1, 2013

First Posted

August 5, 2013

Study Start

August 1, 2013

Primary Completion

May 1, 2018

Study Completion

December 1, 2018

Last Updated

May 20, 2024

Record last verified: 2024-05

Locations