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

NCT ID: NCT00203333

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2010-01-31

Brief Summary

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.

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

Conditions

Refractory Epilepsy; Arrhythmia; Sudden Death

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Medtronic REVEAL

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Refractory epilepsy

Exclusion Criteria

• Other pre-existing heart conditions

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maromi Nei, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18.

Reference Type: RESULT

PMID: 22709423 (View on PubMed)

Other Identifiers

J05901

Identifier Type: -

Identifier Source: org_study_id