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

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.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Embolism, Paradoxical Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Infarction Ischemia Ischemic Stroke Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thromboembolism Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center, Sungkyunkwan University

Seoul, 135710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring

Time frame: Within a month after MRI scanning

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke

Acronym: ICONS

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Sep 7, 2011
Registry last updated: Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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