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Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

This study is currently recruiting participants.
Study NCT00203333.   Last updated on October 23, 2007.   Information provided by Thomas Jefferson University

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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:

  1. the frequency and types of cardiac arrhythmias that occur in this population and
  2. whether these are increased above the general population in the same age group.

Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.

Detailed Description

By employing long-term electrocardiographic monitoring, this study plans to determine:

  1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and
  2. whether these are increased above the general population in the same age group.

The specific aims:

  1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.
  2. Correlate abnormal heart rates and rhythms to specific clinical data:

    1. seizure type,
    2. seizure frequency,
    3. probable location of seizure onset in the brain, when such data are available,
    4. duration of seizures, and
    5. type(s) and number of anticonvulsant medications being used.
  3. Correlate cardiac arrhythmias to clinical symptoms
Study Phase Phase II, Phase III
Study Type  Observational
Study Design  Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Refractory Epilepsy
Arrhythmia
Sudden Death
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:

  • Refractory epilepsy

Exclusion Criteria:

  • Other pre-existing heart conditions
Gender Both
Ages 16 Years to 49 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Gwen Taylor, BA     215-955-4673     gwen.taylor@jefferson.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00203333
Organization ID J05901
Secondary IDs ††
Study Sponsor  Thomas Jefferson University
Collaborators †† Medtronic
Investigators 
Principal Investigator:     Maromi Nei, MD     Thomas Jefferson University    
Information Provided By Thomas Jefferson University
Verification Date April 2007
First Received Date  September 13, 2005
Last Updated Date October 23, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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