NCT02682914

Brief Summary

The main objective of this study is to determine the risk factors and etiologies of ischemic stroke in Korean young adults. Both well-documented risk factors and little known life-style related risk factors such as life-style habits, psychological distress including occupational distress, perceived stress and depression will be evaluated by comparison with healthy controls using a structured questionnaire. Secondary objectives are to determine stroke outcomes such as mortality, recurrent vascular events and post-stroke epilepsy in these patients.

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
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 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

Study Start

First participant enrolled

December 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

February 9, 2016

Last Update Submit

February 10, 2016

Conditions

Keywords

Psychological distressStroke etiologyYoung patients

Outcome Measures

Primary Outcomes (1)

  • Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI

    Through study completion, an average of 4 years

Secondary Outcomes (4)

  • All cause mortality

    4 years

  • Recurrent stoke asked by using questionnaires

    4 years

  • Myocardial infarction asked by using questionnaires

    4 years

  • Post-stroke epilepsy asked by using questionnaires

    4 years

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who had their first-ever ischemic stroke symptoms within the previous month and visited one of the 8 participating tertiary medical centers in the Republic of Korea.

You may qualify if:

  • Age 18 through 44 years
  • First-ever acute ischemic stroke with corresponding lesion on MRI scan

You may not qualify if:

  • Any history of stroke
  • No verification by MRI scan
  • Failure to give their informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University

Seoul, 133-792, South Korea

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Young Seo Kim, Doctor of Philosophy

    Hanynag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Seo Kim, Doctor of Philosophy

CONTACT

Hyuk Sung Kwon, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 17, 2016

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations