Identification the Cause of Silent Cerebral infarctiON in Healthy Subjects (ICONS)
This study has been completed.
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01429948
First received: September 6, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Cerebral Infarction |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke |
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring [ Time Frame: Within a month after MRI scanning ] [ Designated as safety issue: No ]
| Enrollment: | 581 |
| Study Start Date: | April 2008 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Tertiary Hospital
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429948
Locations
| Korea, Republic of | |
| Samsung Medical Center, Sungkyunkwan University | |
| Seoul, Korea, Republic of, 135710 | |
Sponsors and Collaborators
Samsung Medical Center
Investigators
| Principal Investigator: | Oh Young Bang, MD, PhD | Samsung Medical Center, Sungkyunkwan University |
More Information
No publications provided by Samsung Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01429948 History of Changes |
| Other Study ID Numbers: | 2008-02-046 |
| Study First Received: | September 6, 2011 |
| Last Updated: | September 6, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Samsung Medical Center:
|
Stroke, Ischemic Patent foramen ovale Magnetic resonance imaging |
Paradoxical embolism Transcranial Doppler Silent cerebral infarct |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Infarction Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on June 18, 2013