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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Thomas Jefferson University
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203333
First received: September 13, 2005
Last updated: March 28, 2014
Last verified: March 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00203333     History of Changes
Other Study ID Numbers: J05901
Study First Received: September 13, 2005
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Death
Death, Sudden
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014