Clinical trial NCT01429948: Identification the Cause of Silent Cerebral infarctiON in Healthy Subjects (ICONS)
Official title: Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Infarction
Keywords: Stroke, Ischemic
Patent foramen ovale
Magnetic resonance imaging
Paradoxical embolism
Transcranial Doppler
Silent cerebral infarct
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 581
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary Hospital

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.


Eligibility 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

Primary outcomes:
measure: Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring
timeFrame: Within a month after MRI scanning
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University
name: Oh Young Bang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SJ, Shin HY, Ha YS, Kim JW, Kang KW, Na DL, Bang OY. Paradoxical embolism as a cause of silent brain infarctions in healthy subjects: the ICONS study (Identification of the Cause of Silent Cerebral Infarction in Healthy Subjects). Eur J Neurol. 2013 Feb;20(2):353-60. doi: 10.1111/j.1468-1331.2012.03864.x. Epub 2012 Sep 9.