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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203333
First received: September 13, 2005
Last updated: October 17, 2016
Last verified: October 2016
  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: Observational Model: Cohort
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:

Enrollment: 19
Study Start Date: April 2002
Study Completion Date: January 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with refractory focal or generalized epilepsy.
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

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Medtronic
Investigators
Principal Investigator: Maromi Nei, MD Thomas Jefferson University
  More Information

Publications:
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: October 17, 2016

Keywords provided by Thomas Jefferson University:
Epilepsy

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

ClinicalTrials.gov processed this record on January 19, 2017