|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Thomas Jefferson University Medtronic |
| Information provided by: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00203333 |
Purpose
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.
| Condition | Intervention | Phase |
|
Refractory Epilepsy Arrhythmia Sudden Death |
Device: Medtronic REVEAL |
Phase II Phase III |
| Genetics Home Reference related topics: | Brugada syndrome pyridoxal 5'-phosphate-dependent epilepsy short QT syndrome |
| MedlinePlus related topics: | Arrhythmia Epilepsy |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death |
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2002 |
| Estimated Study Completion Date: | June 2006 |
By employing long-term electrocardiographic monitoring, this study plans to determine:
The specific aims:
Correlate abnormal heart rates and rhythms to specific clinical data:
Eligibility
| Ages Eligible for Study: | 16 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gwen Taylor, BA | 215-955-4673 | gwen.taylor@jefferson.edu |
| United States, Pennsylvania | |||||
| Thomas Jefferson University | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| Contact: Megan Morales, BA 215-955-4672 megan.morales@jefferson.edu | |||||
| Principal Investigator: Maromi Nei, MD | |||||
| Thomas Jefferson University |
| Medtronic |
| Principal Investigator: | Maromi Nei, MD | Thomas Jefferson University |
More Information
| Study ID Numbers: | J05901 |
| First Received: | September 13, 2005 |
| Last Updated: | October 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00203333 |
| Health Authority: | United States: Institutional Review Board |
|
|
|
|