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

NCT01429948 | Completed DMC

• 1 other identifier: 2008-02-046
• Study Type: observational
• Target: 581
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Within a month after MRI scanning

Study Arms (3)

Case group

Healthy subjects with silent cerebral infarction

Control group 1

Patients with acute cryptogenic embolic stroke

Control group 2

Patients with acute stroke with conventional stroke mechanisms

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tertiary Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University

Seoul, 135710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22958084 DERIVED

MeSH Terms

Conditions

Cerebral Infarction; Ischemic Stroke; Foramen Ovale, Patent; Embolism, Paradoxical

Condition Hierarchy (Ancestors)

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

Study Officials

• Oh Young Bang, MD, PhD

  Samsung Medical Center, Sungkyunkwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 7, 2011
• Study Start: April 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

KR (1)