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OpenTrials
Completed

NCT Number: NCT00203333

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.

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Key information

Conditions

Refractory Epilepsy Arrhythmia Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Death Death, Sudden Drug Resistant Epilepsy Epilepsy Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Death

Age range

16 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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:
  • seizure type,
  • seizure frequency,
  • probable location of seizure onset in the brain, when such data are available,
  • duration of seizures, and
  • type(s) and number of anticonvulsant medications being used.
  • Correlate cardiac arrhythmias to clinical symptoms

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Refractory epilepsy

Exclusion criteria

  • Other pre-existing heart conditions

Treatment and study plan

Medtronic REVEAL

Device

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2002
Primary completion
2007
Study completion
2010
First posted
Sep 20, 2005
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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