Blood Pressure Variability in Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

— PREVISE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915862
• Other study ID #: AUTH-A7399-1862013
• Status: Completed
• Start date: August 2013
• Est. completion date: December 2018

Study information

• Verified date: May 2024
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: December 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Greece	Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina	Ioannina
Greece	Department of Medicine, Medical School, University of Thessaly, University Hospital of Larissa	Larissa
Greece	First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	A & D Company Limited

Country where clinical trial is conducted

Greece, 

References & 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. — View 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 — View 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/jcm1 — View 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: — View 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 May 14; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)