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

Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01429948

Acronym

ICONS

Enrollment

581

Registered

2011-09-07

Start date

2008-04-30

Completion date

2011-05-31

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Infarction

Keywords

Stroke, Ischemic, Patent foramen ovale, Magnetic resonance imaging, Paradoxical embolism, Transcranial Doppler, Silent cerebral infarct

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results