Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death - Full Text View

Sponsors and Collaborators:	Thomas Jefferson University Medtronic
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203333

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:

the frequency and types of cardiac arrhythmias that occur in this population and
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 II Phase III

Genetics Home Reference related topics: Brugada syndrome pyridoxal 5'-phosphate-dependent epilepsy short QT syndrome

MedlinePlus related topics: Arrhythmia Epilepsy

U.S. FDA Resources

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

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:

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

The specific aims:

Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.
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.
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

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

Keywords provided by Thomas Jefferson University:

Epilepsy

Study placed in the following topic categories:

Death
Heart Diseases
Epilepsy
Death, Sudden

Central Nervous System Diseases
Brain Diseases
Congenital Abnormalities
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009