Post Stroke Epileptic Seizures Risk Forecast | NCT03848273

Studies
Post Stroke Epileptic Seizures Risk Forecast

NCT03848273

Sponsor

Lviv National Medical University

Status

Unknown status

Last Update Posted

Feb 20, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Stroke
Post Stroke Seizure
Post Stroke Epilepsy

Interventions

Not provided

Countries

Ukraine

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2019Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Aug 31, 2022Estimated

First Submitted Date

Jan 23, 2019

First Submission Date that Met QC Criteria

Feb 19, 2019

First Posted Date

Feb 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2019

Last Update Posted Date

Feb 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andriy Kuzminskyy, Assistant of professor, Lviv National Medical UniversityPrincipal Investigator

Lead Sponsor

Lviv National Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ischemic		questionnaire, physical-neurological examination, labor investigations, EEG
Hemorrhagic		questionnaire, physical-neurological examination, labor investigations, EEG
Control		questionnaire, physical-neurological examination, labor investigations, EEG

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First epileptic seizure	Patient's dairy will be used to assess this outcome measure.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Longest seizure-free period	Patient's dairy will be used to assess this outcome measure.	1 year

Other Outcomes

Measure	Description	Time Frame
Death	Coroner report will be used to assess this outcome measure.	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient of Lviv Clinical Emergency Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andriy Kuzminskyy, M.D.	Contact	+380973192791		a.kuzminskyy@gmail.com

Overall Officials

Name	Affiliation	Role
Anzhelika Payenok, MD, DrMedSc, Prof	Danylo Halytsky Lviv National Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danylo Halytsky Lviv National Medical University	Recruiting	Lviv		79010	Ukraine

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D004827	Epilepsy
D012640	Seizures

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided