NCT03510312

Brief Summary

A single-center cohort of patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university and their long-term outcomes.

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
9,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

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, 2011

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

10 years

First QC Date

December 28, 2016

Last Update Submit

March 22, 2021

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (5)

  • Event of Stroke or transient ischemic attack

    The time of a stroke or transient ischemic attack occurs (through study completion)

    through study completion, up to 10 years

  • Event of cardiovascular disease (include stroke/transient ischemic attack)

    The time of a cardiovascular disease (stroke/transient ischemic attack) occurs (through study completion)

    through study completion, up to 10 years

  • All cause mortality

    The time of death from any cause (through study completion)

    through study completion, up to 10 years

  • Cardiovascular cause mortality (include stroke/transient ischemic attack mortality)

    The time of death from cardiovascular cause (through study completion)

    through study completion, up to 10 years

  • The modified Rankin Scale (mRS)

    Measure functional outcome as the form of mRS at 3 months

    3 months

Study Arms (1)

Long-term follow up, observational

This cohort does not involve interventions, just follow up of prognosis of ischemic stroke/transient ischemic attack patients.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with acute ischemic stroke/transient ischemic attack

You may qualify if:

  • All patients with acute ischemic stroke or transient ischemic attack

You may not qualify if:

  • A patient who did not agree with enrollment of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji Hoe Heo

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ji Hoe Heo, MD, PhD

    Yonsei University

    STUDY CHAIR

Central Study Contacts

Ji Hoe Heo, MD, PhD

CONTACT

82-2-2228-1605jhheo@yuhs.ac

Study Design

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

Study Record Dates

First Submitted

December 28, 2016

First Posted

April 27, 2018

Study Start

December 1, 2011

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations

KR(1)