Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00203333
Study type Observational
Source Thomas Jefferson University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date April 2002
Completion date January 2010

See also
  Status Clinical Trial Phase
Recruiting NCT05048602 - Drug-induced Brugada Syndrome Research Database
Completed NCT05053243 - Clinical Validation of the AliveCor Kardia 12L and 6L Devices N/A
Completed NCT01913561 - The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection N/A
Completed NCT01688648 - Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft N/A
Completed NCT01396226 - A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients Phase 2
Terminated NCT00721149 - NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study Phase 3
Completed NCT00756886 - Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study N/A
Terminated NCT00624520 - Mental Stress Reduction in Defibrillator Patients Phase 3
Completed NCT00510029 - Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously Phase 1
Completed NCT00578617 - Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial N/A
Active, not recruiting NCT00135174 - Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study N/A
Completed NCT00119847 - Electrophysiological Effects of Late PCI After MI N/A
Completed NCT00035490 - Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators Phase 3
Completed NCT00023556 - Genetic Architecture of Heart Disease in Rural Brazil N/A
Completed NCT01076361 - Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study N/A
Completed NCT00004560 - Public Access Defibrillation (PAD) Community Trial Phase 3
Recruiting NCT00138931 - Genetics of Cardiovascular and Neuromuscular Disease
Completed NCT00622453 - Arrhythmias in Myotonic Muscular Dystrophy N/A
Completed NCT01076348 - Model 4965 Post-Approval Study
Completed NCT00000531 - Antiarrhythmics Versus Implantable Defibrillators (AVID) Phase 3