Korean Transient Ischemic Attack eXpression Registry | NCT01870531

Studies
Korean Transient Ischemic Attack eXpression Registry

NCT01870531

Sponsor

Seoul National University Boramae Hospital

Status

Completed

Last Update Posted

Jun 9, 2015Estimated

Enrollment

500Actual

Phase

Not provided

Conditions

Transient Ischemic Attack

Interventions

Not provided

Countries

South Korea

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Mar 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

May 23, 2013

First Submission Date that Met QC Criteria

Jun 5, 2013

First Posted Date

Jun 6, 2013Estimated

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

Jun 6, 2015

Last Update Posted Date

Jun 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yong-Seok Lee, Professor, Seoul National University Boramae HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Boramae HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study is to determine the clinical and neuroimaging characteristics of Transient Ischemic Attacks in Korean populations.

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

Yes

Target Follow-Up Duration

90 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vascular events including ischemic strokes, myocardial infarctions, cardiovascular deaths		90 days

Secondary Outcomes

Measure	Description	Time Frame
Recurrent transient ischemic attacks		90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical symptoms and signs consistent with transient ischemic attack
Subject who admitted hospital within 24 hours after symptom onset
Subjects who underwent MRI (including diffusion-weighted images) and MRA (or CT angiography)

Exclusion Criteria:

Transient neurological symptoms due to

Migraine aura
Basilar migraine
Seizures
Syncope
Peripheral vertigo
Transient global amnesia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

University Hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yong-Seok Lee, MD, PhD	Seoul National University Boramae Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Boramae Hospital		Seoul	Seoul	156-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002546	Ischemic Attack, Transient

Ancestor Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided