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| Descriptive Information Fields | |||||
| Brief Title † | Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death | ||||
| Official Title † | Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death | ||||
| Brief Summary | People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP. This study plans to determine:
Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms. |
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| Detailed Description | By employing long-term electrocardiographic monitoring, this study plans to determine:
The specific aims:
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| Study Phase | Phase II, Phase III | ||||
| Study Type † | Observational | ||||
| Study Design † | Prospective | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Refractory Epilepsy Arrhythmia Sudden Death |
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| Intervention † | Device: Medtronic REVEAL | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 20 | ||||
| Start Date † | April 2002 | ||||
| Completion Date | June 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 49 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00203333 | ||||
| Organization ID | J05901 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Thomas Jefferson University | ||||
| Collaborators †† | Medtronic | ||||
| Investigators † |
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| Information Provided By | Thomas Jefferson University | ||||
| Verification Date | April 2007 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | October 23, 2007 | ||||