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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01429948
First received: September 6, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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.


Condition
Cerebral Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring [ Time Frame: Within a month after MRI scanning ] [ Designated as safety issue: No ]

Enrollment: 581
Study Start Date: April 2008
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Tertiary Hospital

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429948

Locations
Korea, Republic of
Samsung Medical Center, Sungkyunkwan University
Seoul, Korea, Republic of, 135710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Oh Young Bang, MD, PhD Samsung Medical Center, Sungkyunkwan University
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01429948     History of Changes
Other Study ID Numbers: 2008-02-046
Study First Received: September 6, 2011
Last Updated: September 6, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Stroke, Ischemic
Patent foramen ovale
Magnetic resonance imaging
Paradoxical embolism
Transcranial Doppler
Silent cerebral infarct

Additional relevant MeSH terms:
Cerebral Infarction
Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014