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

Cerebral Infarction Clinical Trial

— ICONS  

Official title:

Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429948
• Other study ID #: 2008-02-046
• Status: Completed
• Phase: N/A
• First received: September 6, 2011
• Last updated: September 6, 2011
• Start date: April 2008
• Est. completion date: May 2011

Study information

• Verified date: September 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 581
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring		Within a month after MRI scanning	No