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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003643', 'term': 'Death'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epilepsy'], 'conditions': ['Refractory Epilepsy', 'Arrhythmia', 'Sudden Death']}, 'referencesModule': {'references': [{'pmid': '22709423', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis study plans to determine:\n\n1. the frequency and types of cardiac arrhythmias that occur in this population and\n2. whether these are increased above the general population in the same age group.\n\nAdditionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.', 'detailedDescription': 'By employing long-term electrocardiographic monitoring, this study plans to determine:\n\n1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and\n2. whether these are increased above the general population in the same age group.\n\nThe specific aims:\n\n1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.\n2. Correlate abnormal heart rates and rhythms to specific clinical data:\n\n 1. seizure type,\n 2. seizure frequency,\n 3. probable location of seizure onset in the brain, when such data are available,\n 4. duration of seizures, and\n 5. type(s) and number of anticonvulsant medications being used.\n3. Correlate cardiac arrhythmias to clinical symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with refractory focal or generalized epilepsy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractory epilepsy\n\nExclusion Criteria:\n\n* Other pre-existing heart conditions'}, 'identificationModule': {'nctId': 'NCT00203333', 'briefTitle': 'Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death', 'orgStudyIdInfo': {'id': 'J05901'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medtronic REVEAL', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Maromi Nei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}