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Stroke in Korean Young Adults Study (SKY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682914
Recruitment Status : Unknown
Verified February 2016 by Young Seo Kim, Hanyang University.
Recruitment status was:  Recruiting
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Collaborators:
Hallym University Medical Center
Seoul National University Hospital
Seoul National University Bundang Hospital
Severance Hospital
Seoul National University Boramae Hospital
Kyung Hee University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Cerebrovascular Research Club
Information provided by (Responsible Party):
Young Seo Kim, Hanyang University

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.

Condition or disease
Ischemic Stroke

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 470 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Study Start Date : December 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI [ Time Frame: Through study completion, an average of 4 years ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 4 years ]
    Information will be obtained from participant's last practitioner or care-giver.

  2. Recurrent stoke asked by using questionnaires [ Time Frame: 4 years ]
    Minimum necessary time interval between original event and recurrent stoke is 21 days. If a stroke occured within 21 days, it has to be located in the different vascular territory as the original event.

  3. Myocardial infarction asked by using questionnaires [ Time Frame: 4 years ]
    Subsequent fatal or nonfatal myocardial infarction

  4. Post-stroke epilepsy asked by using questionnaires [ Time Frame: 4 years ]
    Two or more unprovoked epileptic seizures occuring at ≥1 week after the ischemic stroke event.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

  1. Age 18 through 44 years
  2. First-ever acute ischemic stroke with corresponding lesion on MRI scan
  3. Onset of symptoms within 1 months of inclusion

Exclusion Criteria:

  1. Any history of stroke
  2. No verification by MRI scan
  3. Failure to give their informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682914


Contacts
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Contact: Young Seo Kim, Doctor of Philosophy 82-2-2290-8375 aescula@hanmail.net
Contact: Hyuk Sung Kwon, master 82-2-2290-8375 hamohamo1318@gmail.com

Locations
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Korea, Republic of
Hanyang University Recruiting
Seoul, Korea, Republic of, 133-792
Contact: Young Seo Kim, Professor    82-2-2290-8375    aescula@hanmail.net   
Sponsors and Collaborators
Hanyang University
Hallym University Medical Center
Seoul National University Hospital
Seoul National University Bundang Hospital
Severance Hospital
Seoul National University Boramae Hospital
Kyung Hee University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Cerebrovascular Research Club
Investigators
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Principal Investigator: Young Seo Kim, Doctor of Philosophy Hanynag University
Additional Information:

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Responsible Party: Young Seo Kim, Professor, Hanyang University
ClinicalTrials.gov Identifier: NCT02682914    
Other Study ID Numbers: HYUH 2013-10-018
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Young Seo Kim, Hanyang University:
Psychological distress
Stroke etiology
Young patients
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases