NCT03848273

Brief Summary

Improve the effectiveness of treatment and prognosis in patients with cerebrovascular accident by early detection of the risk of developing epileptic seizures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 23, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

January 23, 2019

Last Update Submit

February 19, 2019

Conditions

Keywords

strokeepilepsyseizureEEG

Outcome Measures

Primary Outcomes (1)

  • First epileptic seizure

    Patient's dairy will be used to assess this outcome measure.

    1 year

Secondary Outcomes (1)

  • Longest seizure-free period

    1 year

Other Outcomes (1)

  • Death

    1 year

Study Arms (3)

Ischemic

questionnaire, physical-neurological examination, labor investigations, EEG

Hemorrhagic

questionnaire, physical-neurological examination, labor investigations, EEG

Control

questionnaire, physical-neurological examination, labor investigations, EEG

Eligibility Criteria

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

Patient of Lviv Clinical Emergency Hospital

You may qualify if:

  • informed consent to participate in the study signed by the patient / relative of the patient / the legal representative of the patient
  • age over 18 years
  • stroke, confirmed by neuroimaging
  • light to moderate stroke (score on National Institutes of Health Stroke Scale).

You may not qualify if:

  • recanalization therapy
  • previous epileptic seizures and history of epilepsy
  • psychiatric diseases in history
  • previous stroke
  • traumatic brain injury
  • brain tumors.
  • inflammatory and infectious diseases
  • decompensated physical illness.
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danylo Halytsky Lviv National Medical University

Lviv, 79010, Ukraine

RECRUITING

MeSH Terms

Conditions

StrokeEpilepsySeizures

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anzhelika Payenok, MD, DrMedSc, Prof

    Danylo Halytsky Lviv National Medical University

    STUDY CHAIR

Central Study Contacts

Andriy Kuzminskyy, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant of professor

Study Record Dates

First Submitted

January 23, 2019

First Posted

February 20, 2019

Study Start

February 20, 2019

Primary Completion

December 31, 2020

Study Completion

August 31, 2022

Last Updated

February 20, 2019

Record last verified: 2019-02

Locations