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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   Information provided by Thomas Jefferson University
First Received: September 13, 2005   Last Updated: October 23, 2007   History of Changes

September 13, 2005
October 23, 2007
April 2002
 
 
 
Complete list of historical versions of study NCT00203333 on ClinicalTrials.gov Archive Site
 
 
 
Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death
Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

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.

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
Phase II, Phase III
Observational
Prospective
  • Refractory Epilepsy
  • Arrhythmia
  • Sudden Death
Device: Medtronic REVEAL
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
June 2006
 

Inclusion Criteria:

  • Refractory epilepsy

Exclusion Criteria:

  • Other pre-existing heart conditions
Both
16 Years to 49 Years
No
Contact: Gwen Taylor, BA 215-955-4673 gwen.taylor@jefferson.edu
United States
 
NCT00203333
 
J05901
Thomas Jefferson University
Medtronic
Principal Investigator: Maromi Nei, MD Thomas Jefferson University
Thomas Jefferson University
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP