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

Last updated: September 6, 2011
Sponsor: Samsung Medical Center
Overall Status: Completed

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Occlusions

Treatment

N/A

Clinical Study ID

NCT01429948
2008-02-046
  • Ages > 20
  • All Genders

Study 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

Inclusion Criteria: Healthy subjects

  • Subjects with age over 20 years

  • Subjects who consecutively visited a health promotion center for a health screeningexamination that included routine laboratory test, cardiac work-ups (12-leadelectrocardiography 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 focalhyperintensity lesion 3 mm or large in diameter in the fluid-attenuation inversionrecovery (FLAIR) images without a history of a corresponding stroke or transientischemic attack (TIA)

  • Subjects who performed agitated saline transcranial Doppler (TCD) monitoring Patients with acute stroke (both cryptogenic embolic stroke and conventional strokemechanisms)

  • 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

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 statusexamination

  • Subjects with the presence of proximal source of embolism, including atrialfibrillation or significant (≥50%) stenosis on cervicocerebral artery on MRA orcarotid Duplex

  • Subjects who had SCI restricted within perforator territory (basal ganglia or pons)suggesting that microangiopathy rather than embolism could be the main mechanism ofSCI

  • Subjects in whom agitated saline TCD monitoring was not performed or those who hadpoor temporal windows Patients with acute stroke (both cryptogenic embolic stroke and conventional strokemechanisms)

  • Patients in whom agitated saline TCD monitoring was not performed or those who hadpoor temporal windows

Study Design

Total Participants: 581
Study Start date:
April 01, 2008
Estimated Completion Date:
May 31, 2011

Connect with a study center

  • Samsung Medical Center, Sungkyunkwan University

    Seoul, 135710
    Korea, Republic of

    Site Not Available

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