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

NCT ID: NCT01429948

Last Updated: 2011-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 581 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-05-31

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.

Conditions

Cerebral Infarction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case group

Healthy subjects with silent cerebral infarction

No interventions assigned to this group

Control group 1

Patients with acute cryptogenic embolic stroke

No interventions assigned to this group

Control group 2

Patients with acute stroke with conventional stroke mechanisms

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oh Young Bang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Sungkyunkwan University

Locations

Samsung Medical Center, Sungkyunkwan University

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 22958084 (View on PubMed)

Other Identifiers

2008-02-046

Identifier Type: -

Identifier Source: org_study_id