Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00203333
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: