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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00391378 |
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Date of registration:
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21/10/2006 |
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Primary sponsor: |
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Public title:
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Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
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Scientific title:
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Cerebral Lesions and Outcomes After Cardiac Surgery (CLOCS) |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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363 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00391378 |
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Study type:
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Observational |
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Study design:
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N/A
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
- Age 18 years or greater
- Neurologically and cognitively independent prior to surgery (mRS less than 2)
- CABG, aortic or mitral valve replacement, or a combined valve/CABG procedure
scheduled within one week
EXCLUSION CRITERIA:
- Planned concomitant carotid endarterectomy
- Concomitant medical disorders making clinical follow-up of at least 6 months unlikely
or impossible (e.g., neoplastic disease, hepatic failure)
- History of dementia, cognitive dysfunction (MMSE score less than 24) or psychotic
disorder
- Any current MRI contraindication (cardiac pacemaker or defibrillator, insulin pump,
aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or
bullet, etc)
- Definite or possible pacemaker placement at the time of or after surgery
- Inability to give informed consent
- Pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cognitive Symptoms
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Stroke
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Secondary ID(s)
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06-N-N245
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999906245
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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