Ischemic StrokePREVISENCT01915862
Blood Pressure Variability in Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by Aristotle University Of Thessaloniki at 3 sites in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 353 participants
- Where
- 3 sitesGreece
- Study dates
- Aug 2013to Dec 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients admitted to Departments of Medicine of three University Hospitals (Thessaloniki, Larissa, Ioannina) with the diagnosis of acute ischemic stroke
Who may be able to join
- Acute ischemic stroke
- Admission within 24 after the onset of symptoms
Who cannot join
- Transient ischemic attack
- Intracerebral hemorrhage
- Subarachnoid hemorrhage
- Cerebral sinus venous thrombosis
- Stroke mimics
- Late admission (>24 hours after stroke onset)
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
Second Department of Internal Medicine, Medical School, University of Ioannina, University Hospital of Ioannina
Ioannina, 45110
Department of Medicine, Medical School, University of Thessaly, University Hospital of Larissa
Larissa, 41110
First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital
Thessaloniki, 54636
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Keywords
- Acute ischemic stroke, Blood pressure variability, Ambulatory arterial stiffness index, Ambulatory blood pressure monitoring, Outcome
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Three months (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- A & D Company Limited
- Responsible party
- Principal investigator, Nikolaos Kakaletsis, Aristotle University Of Thessaloniki
- Investigators
- Apostolos I. Hatzitolios, MD, PhD, Study director, Aristotle University of Thessaloniki, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915862
- Sponsor's protocol ID
- AUTH-A7399-1862013
- Acronym
- PREVISE
- Status last verified
- May 2024
- First submitted
- 1 Aug 2013
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26283262Kakaletsis 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.
PubMed 35666577Kakaletsis 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.
PubMed 36583356Kakaletsis 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.
PubMed 37510931Karagiannaki 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.
PubMed 38754240
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01915862
- Acronym / sponsor ID
- PREVISE / AUTH-A7399-1862013
- Conditions
- Ischemic Stroke
- Keywords
- Acute ischemic stroke, Blood pressure variability, Ambulatory arterial stiffness index, Ambulatory blood pressure monitoring, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- A & D Company Limited
- Study start
- Aug 2013
- Primary completion
- May 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted to Departments of Medicine of three University Hospitals (Thessaloniki, Larissa, Ioannina) with the diagnosis of acute ischemic stroke
Key inclusion criteria (2 listed)
- Acute ischemic stroke
- Admission within 24 after the onset of symptoms
Key exclusion criteria (6 listed)
- Transient ischemic attack
- Intracerebral hemorrhage
- Subarachnoid hemorrhage
- Cerebral sinus venous thrombosis
- Stroke mimics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rankin Scale Score (mRS)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Background: PubMed 26283262Kakaletsis 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.
- Results publication: PubMed 35666577Kakaletsis 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.
- Results publication: PubMed 36583356Kakaletsis 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.
- Results publication: PubMed 37510931Kakaletsis 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.
- Results publication: PubMed 38754240Karagiannaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apostolos I. Hatzitolios, MD, PhD study director
Aristotle University of Thessaloniki, AHEPA University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Aristotle University Of Thessaloniki at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale Score (mRS) (time frame: Three months (90 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915862, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.