Identification the Cause of Silent Cerebral infarctiON in Healthy Subjects (ICONS) (ICONS)

September 6, 2011 updated by: Samsung Medical Center

Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke

We hypothesized that paradoxical embolism may be one of the main mechanisms of silent cerebral infarction (SCI) located outside the perforating artery territory. In the present study, we evaluated the association between SCI and paradoxical embolism detected by agitated saline transcranial Doppler (TCD) monitoring in healthy subjects without history of stroke or transient ischemic attack (TIA). We also compared the frequency and amount of paradoxical embolism between healthy subjects with SCI and acute stroke patients with presumed cryptogenic embolism or conventional stroke mechanisms.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

581

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135710
        • Samsung Medical Center, Sungkyunkwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Tertiary Hospital

Description

Inclusion Criteria:

Healthy subjects

  • Subjects with age over 20 years
  • Subjects who consecutively visited a health promotion center for a health screening examination that included routine laboratory test, cardiac work-ups (12-lead electrocardiography and/or echocardiography), and brain magnetic resonance image (MRI) and MR angiography (MRA)
  • Subjects who showed silent brain infarction (SCI) which was defined as a focal hyperintensity lesion 3 mm or large in diameter in the fluid-attenuation inversion recovery (FLAIR) images without a history of a corresponding stroke or transient ischemic attack (TIA)
  • Subjects who performed agitated saline transcranial Doppler (TCD) monitoring

Patients with acute stroke (both cryptogenic embolic stroke and conventional stroke mechanisms)

  • Patients with age over 20 year
  • Patients with focal neurologic deficits presented within 7 days of symptom onset
  • Patients with acute ischemic lesions on diffusion-weighted image (DWI)
  • Patients who performed agitated saline TCD monitoring

Exclusion Criteria:

Healthy subjects

  • Subjects with the presence of previous history of stroke or TIA
  • Subjects with the presence of dementia on history taking or mini-mental status examination
  • Subjects with the presence of proximal source of embolism, including atrial fibrillation or significant (≥50%) stenosis on cervicocerebral artery on MRA or carotid Duplex
  • Subjects who had SCI restricted within perforator territory (basal ganglia or pons) suggesting that microangiopathy rather than embolism could be the main mechanism of SCI
  • Subjects in whom agitated saline TCD monitoring was not performed or those who had poor temporal windows

Patients with acute stroke (both cryptogenic embolic stroke and conventional stroke mechanisms)

  • Patients in whom agitated saline TCD monitoring was not performed or those who had poor temporal windows

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case group
Healthy subjects with silent cerebral infarction
Control group 1
Patients with acute cryptogenic embolic stroke
Control group 2
Patients with acute stroke with conventional stroke mechanisms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring
Time Frame: Within a month after MRI scanning
Within a month after MRI scanning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Oh Young Bang, MD, PhD, Samsung Medical Center, Sungkyunkwan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 6, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-02-046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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