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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Thomas Jefferson University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203333
First received: September 13, 2005
Last updated: October 23, 2007
Last verified: April 2007
History of Changes
  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:

  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.


Condition Intervention Phase
Refractory Epilepsy
Arrhythmia
Sudden Death
 Device: Medtronic REVEAL
 Phase 2
Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia Epilepsy
U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Estimated Enrollment: 20
Study Start Date: April 2002
Estimated Study Completion Date: June 2006
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
  Eligibility

Ages Eligible for Study:   16 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Refractory epilepsy

Exclusion Criteria:

  • Other pre-existing heart conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203333

Contacts
Contact: Gwen Taylor, BA 215-955-4673 gwen.taylor@jefferson.edu

Locations
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            
Sponsors and Collaborators
Thomas Jefferson University
Medtronic
Investigators
Principal Investigator: Maromi Nei, MD Thomas Jefferson University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00203333     History of Changes
Other Study ID Numbers: J05901
Study First Received: September 13, 2005
Last Updated: October 23, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Epilepsy

Additional relevant MeSH terms:
Congenital Abnormalities
Arrhythmias, Cardiac
Death
Death, Sudden
Epilepsy
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013