Convulsive Status EPILEPTICUSNCT06119919
Cardiac Injury With Convulsive Status Epilepticus
An observational study of Convulsive Status EPILEPTICUS, run by Assiut University.
Trial summary
1. Determine the impact of cardiac injury on clinical profile, cardiac evaluation and outcome in patients hospitalized with convulsive status epilepticus (CSE). 2. Analyze the frequency of cardiac rhythm and conduction abnormalities related to seizures and determine risk factors and associated clinical… Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Convulsive Status EPILEPTICUS
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- Child
Study population: all children admitted in Assiut University Hospitals Pediatrics department from 1 month to 16 years with convulsive status epilepticus
Who may be able to join
- children aged 1 month to 16 years presented with Convulsions
- convulsions lasts more than 5 minutes or recurrent seizures without regaining consciousness in-between
Who cannot join
- Patients with hepatic diseases
- patients with chronic renal illness
- patients with endocrinal diseases
- patients with musculoskeletal abnormalities
- children with sepsis
- congenital heart disease, myocarditis, myocardial disease, or arrhythmias; and children who survived cardiac surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cardiac Injury and it's Relation to Convulsive Status Epilepticus in Children
- Determine the impact of cardiac injury on clinical profile, cardiac evaluation and outcome in patients hospitalized with convulsive status epilepticus (CSE).
- Analyze the frequency of cardiac rhythm and conduction abnormalities related to seizures and determine risk factors and associated clinical characteristics.
- Analyse ECG abnormalities and changes in HR in epileptic seizures since such disturbances might be a factor in SUDEP
- Assessment of levels of cardiac enzymes in patients with status epilepticus
Read the detailed description
- Convulsive status epilepticus (CSE) is the most common life- threatening pediatric neurological emergency, with high morbidity and mortality rates . Previously, status epilepticus was defined as a seizure lasting more than 30 min . However, more recently, status epilepticus is considered if a patient has continuous seizure activity for 5 min or recurrent seizures without regaining consciousness level in between .
- Cardiac injury in CSE is associated with a combination of excessive catecholamine release, sympathetic overflow, and subsequent neurogenic myocardial stunning, resulting in subtle structural and functional myocardial damage with a high incidence of arrhythmia, stress-related cardiomyopathy, and heart failure moreover, cardiac injury may be iatrogenic due to intravenous fluid overload and cardio-depressive effects of anti-seizure medications (ASMs). Most of the SE-induced deaths occurring within 30 days following seizure activity are attributed to lethal cardiac arrhythmia, pulmonary edema, hypotension, and circulatory collapse
- Cardiac injury was defined as one or more of the following: (a) cardiac troponin ≥ 99th percentile , corrected for age and sex and (b) new- onset ECG changes categorized into ischemic changes, conduction abnormalities, or arrhythmias . (c) Left ventricular systolic or diastolic dysfunction, which is defined as follows: systolic dysfunction if EF < 56% and/or FS < 28% , diastolic dysfunction is defined and classified according to the recommendations of the American Society of Echocardiography and the European Association of Cardiovascular Imaging
- Changes in cardiac function in epilepsy imply an activation of the central autonomic network. In patients with seizures, epileptic discharges are thought to propagate to the central autonomic network and change or disturb normal autonomic control of vital cardiac functions. This activation of central autonomic nervous system is thought to be responsible for the peri-ictal autonomic cardiac symptoms observed in epilepsy patients. The importance of these autonomic features in the pathophysiology of epilepsy and its complications has become more clear in the last years.
- Conduction disorders seem to be common during seizures in intractable epilepsy could demonstrate the presence of arrhythmias or conduction disorders in seizures, particularly if these are prolonged or generalized. They include atrial fibrillation, supraventricular tachycardia and atrial and ventricular premature depolarisation. EKG changes, including T-wave inversion and ST-depression, were more frequent and potentially more dangerous in patients with generalized seizures.
- excessive autonomic stimulation may result in cardiac arrhythmias. But repetitive autonomic stimulation can also lead to structural damage to the heart. This increases the susceptibility to cardiac arrhythmias or ischemia. Myocardial fibrosis has already been found . Patients with uncomplicated seizures do not seem to have postictal troponin elevation, but signs of ischemia on ECG and elevated cardiac enzymes in epileptic patients suggest secondary cardiac damage could show presence of elevated Brain Natriuretic Peptide " BNP "and Creatine kinase Myocardial Band "CK-MB" in patients with seizures, the first evidence of subtle cardiac dysfunction in epilepsy patients.
- Cardiovascular-specific biomarkers have been identified as the most accurate indicators of myocardial infarction. Cardiovascular troponin-I (cTnI), in particular, is extremely selective for myocardial muscular tissue injury and is never produced following skeletal muscle injury .
- Patients with longlasting and multiple seizures seem to be prone to chronic dysfunction of autonomic cardiac control. In patients with newly diagnosed (median time 27 months) and untreated epilepsy, no difference was found in heart rate variability studied well controlled patients and refractory patients and could show with a series of autonomic tests that higher vasomotor tone, higher sympathetic tone, lower parasympathetic tone and reactivity was found in the group of refractory epilepsy patients. The observed dysautonomia could be a predisposing factor to SUDEP -sudden unexpected death in epilepsy. could demonstrate altered cardiovagal control in patients with chronic epilepsy.
- Conditions
- Convulsive Status EPILEPTICUS
- Medical subject headings
- Status Epilepticus
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac injury and convulsive status epilepticus
Determine the impact of cardiac injury on clinical profile and outcome in patients with convulsive status epilepticus
Measured: baseline
Cardiac injury and convulsive status epilepticus
Analyze the frequency of cardiac rhythm and conduction abnormalities
Measured: Baseline
Cardiac injury and convulsive status epilepticus
Analyze ECG abnormalities and heart rate changes
Measured: Baseline
Cardiac injury and convulsive status epilepticus
Assessment of levels of cardiac enzymes in patients with status epilepticus
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Convulsive Status EPILEPTICUSStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christin Emad Ragheb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119919
- Sponsor's protocol ID
- Cardiac injury and epilepsy
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fogarasi A, Janszky J, Tuxhorn I. Autonomic symptoms during childhood partial epileptic seizures. Epilepsia. 2006 Mar;47(3):584-8. doi: 10.1111/j.1528-1167.2006.00472.x.
PubMed 16529626Janszky J, Fogarasi A, Toth V, Magalova V, Gyimesi C, Kovacs N, Schulz R, Ebner A. Peri-ictal vegetative symptoms in temporal lobe epilepsy. Epilepsy Behav. 2007 Aug;11(1):125-9. doi: 10.1016/j.yebeh.2007.04.015. Epub 2007 Jun 20.
PubMed 17584534Widdess-Walsh P, Kotagal P, Jeha L, Wu G, Burgess R. Multiple auras: clinical significance and pathophysiology. Neurology. 2007 Aug 21;69(8):755-61. doi: 10.1212/01.wnl.0000267650.50269.5d.
PubMed 17709707Baumgartner C, Lurger S, Leutmezer F. Autonomic symptoms during epileptic seizures. Epileptic Disord. 2001 Sep;3(3):103-16.
PubMed 11679301Nei M, Ho RT, Sperling MR. EKG abnormalities during partial seizures in refractory epilepsy. Epilepsia. 2000 May;41(5):542-8. doi: 10.1111/j.1528-1157.2000.tb00207.x.
PubMed 10802759Natelson BH, Suarez RV, Terrence CF, Turizo R. Patients with epilepsy who die suddenly have cardiac disease. Arch Neurol. 1998 Jun;55(6):857-60. doi: 10.1001/archneur.55.6.857.
PubMed 9626779Woodruff BK, Britton JW, Tigaran S, Cascino GD, Burritt MF, McConnell JP, Ravkilde J, Molgaard H, Andreasen F, Dam M, Jaffe AS. Cardiac troponin levels following monitored epileptic seizures. Neurology. 2003 May 27;60(10):1690-2. doi: 10.1212/01.wnl.0000065881.46964.4f.
PubMed 12771269Tigaran S, Molgaard H, McClelland R, Dam M, Jaffe AS. Evidence of cardiac ischemia during seizures in drug refractory epilepsy patients. Neurology. 2003 Feb 11;60(3):492-5. doi: 10.1212/01.wnl.0000042090.13247.48.
PubMed 12578934Chin RF, Neville BG, Peckham C, Bedford H, Wade A, Scott RC; NLSTEPSS Collaborative Group. Incidence, cause, and short-term outcome of convulsive status epilepticus in childhood: prospective population-based study. Lancet. 2006 Jul 15;368(9531):222-9. doi: 10.1016/S0140-6736(06)69043-0.
PubMed 16844492Mitchell WG. Status epilepticus and acute serial seizures in children. J Child Neurol. 2002 Jan;17 Suppl 1:S36-43. doi: 10.1177/08830738020170010501.
PubMed 11918461
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Injury and it's Relation to Convulsive Status Epilepticus in Children
- ClinicalTrials.gov ID
- NCT06119919
- Acronym / sponsor ID
- Cardiac injury and epilepsy
- Conditions
- Convulsive Status EPILEPTICUS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Determine the impact of cardiac injury on clinical profile, cardiac evaluation and outcome in patients hospitalized with convulsive status epilepticus (CSE).
- Analyze the frequency of cardiac rhythm and conduction abnormalities related to seizures and determine risk factors and associated clinical characteristics.
- Analyse ECG abnormalities and changes in HR in epileptic seizures since such disturbances might be a factor in SUDEP
- Assessment of levels of cardiac enzymes in patients with status epilepticus
Detailed description
- Convulsive status epilepticus (CSE) is the most common life- threatening pediatric neurological emergency, with high morbidity and mortality rates . Previously, status epilepticus was defined as a seizure lasting more than 30 min . However, more recently, status epilepticus is considered if a patient has continuous seizure activity for 5 min or recurrent seizures without regaining consciousness level in between .
- Cardiac injury in CSE is associated with a combination of excessive catecholamine release, sympathetic overflow, and subsequent neurogenic myocardial stunning, resulting in subtle structural and functional myocardial damage with a high incidence of arrhythmia, stress-related cardiomyopathy, and heart failure moreover, cardiac injury may be iatrogenic due to intravenous fluid overload and cardio-depressive effects of anti-seizure medications (ASMs). Most of the SE-induced deaths occurring within 30 days following seizure activity are attributed to lethal cardiac arrhythmia, pulmonary edema, hypotension, and circulatory collapse
- Cardiac injury was defined as one or more of the following: (a) cardiac troponin ≥ 99th percentile , corrected for age and sex and (b) new- onset ECG changes categorized into ischemic changes, conduction abnormalities, or arrhythmias . (c) Left ventricular systolic or diastolic dysfunction, which is defined as follows: systolic dysfunction if EF < 56% and/or FS < 28% , diastolic dysfunction is defined and classified according to the recommendations of the American Society of Echocardiography and the European Association of Cardiovascular Imaging
- Changes in cardiac function in epilepsy imply an activation of the central autonomic network. In patients with seizures, epileptic discharges are thought to propagate to the central autonomic network and change or disturb normal autonomic control of vital cardiac functions. This activation of central autonomic nervous system is thought to be responsible for the peri-ictal autonomic cardiac symptoms observed in epilepsy patients. The importance of these autonomic features in the pathophysiology of epilepsy and its complications has become more clear in the last years.
- Conduction disorders seem to be common during seizures in intractable epilepsy could demonstrate the presence of arrhythmias or conduction disorders in seizures, particularly if these are prolonged or generalized. They include atrial fibrillation, supraventricular tachycardia and atrial and ventricular premature depolarisation. EKG changes, including T-wave inversion and ST-depression, were more frequent and potentially more dangerous in patients with generalized seizures.
- excessive autonomic stimulation may result in cardiac arrhythmias. But repetitive autonomic stimulation can also lead to structural damage to the heart. This increases the susceptibility to cardiac arrhythmias or ischemia. Myocardial fibrosis has already been found . Patients with uncomplicated seizures do not seem to have postictal troponin elevation, but signs of ischemia on ECG and elevated cardiac enzymes in epileptic patients suggest secondary cardiac damage could show presence of elevated Brain Natriuretic Peptide " BNP "and Creatine kinase Myocardial Band "CK-MB" in patients with seizures, the first evidence of subtle cardiac dysfunction in epilepsy patients.
- Cardiovascular-specific biomarkers have been identified as the most accurate indicators of myocardial infarction. Cardiovascular troponin-I (cTnI), in particular, is extremely selective for myocardial muscular tissue injury and is never produced following skeletal muscle injury .
- Patients with longlasting and multiple seizures seem to be prone to chronic dysfunction of autonomic cardiac control. In patients with newly diagnosed (median time 27 months) and untreated epilepsy, no difference was found in heart rate variability studied well controlled patients and refractory patients and could show with a series of autonomic tests that higher vasomotor tone, higher sympathetic tone, lower parasympathetic tone and reactivity was found in the group of refractory epilepsy patients. The observed dysautonomia could be a predisposing factor to SUDEP -sudden unexpected death in epilepsy. could demonstrate altered cardiovagal control in patients with chronic epilepsy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- all children admitted in Assiut University Hospitals Pediatrics department from 1 month to 16 years with convulsive status epilepticus
Key inclusion criteria (2 listed)
- children aged 1 month to 16 years presented with Convulsions
- convulsions lasts more than 5 minutes or recurrent seizures without regaining consciousness in-between
Key exclusion criteria (6 listed)
- Patients with hepatic diseases
- patients with chronic renal illness
- patients with endocrinal diseases
- patients with musculoskeletal abnormalities
- children with sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiac injury and convulsive status epilepticus
Time frame: baseline
Determine the impact of cardiac injury on clinical profile and outcome in patients with convulsive status epilepticus
Cardiac injury and convulsive status epilepticus
Time frame: Baseline
Analyze the frequency of cardiac rhythm and conduction abnormalities
Cardiac injury and convulsive status epilepticus
Time frame: Baseline
Analyze ECG abnormalities and heart rate changes
Cardiac injury and convulsive status epilepticus
Time frame: Baseline
Assessment of levels of cardiac enzymes in patients with status epilepticus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 16529626Fogarasi A, Janszky J, Tuxhorn I. Autonomic symptoms during childhood partial epileptic seizures. Epilepsia. 2006 Mar;47(3):584-8. doi: 10.1111/j.1528-1167.2006.00472.x.
- Background: PubMed 17584534Janszky J, Fogarasi A, Toth V, Magalova V, Gyimesi C, Kovacs N, Schulz R, Ebner A. Peri-ictal vegetative symptoms in temporal lobe epilepsy. Epilepsy Behav. 2007 Aug;11(1):125-9. doi: 10.1016/j.yebeh.2007.04.015. Epub 2007 Jun 20.
- Background: PubMed 17709707Widdess-Walsh P, Kotagal P, Jeha L, Wu G, Burgess R. Multiple auras: clinical significance and pathophysiology. Neurology. 2007 Aug 21;69(8):755-61. doi: 10.1212/01.wnl.0000267650.50269.5d.
- Background: PubMed 11679301Baumgartner C, Lurger S, Leutmezer F. Autonomic symptoms during epileptic seizures. Epileptic Disord. 2001 Sep;3(3):103-16.
- Background: PubMed 10802759Nei M, Ho RT, Sperling MR. EKG abnormalities during partial seizures in refractory epilepsy. Epilepsia. 2000 May;41(5):542-8. doi: 10.1111/j.1528-1157.2000.tb00207.x.
- Background: PubMed 9626779Natelson BH, Suarez RV, Terrence CF, Turizo R. Patients with epilepsy who die suddenly have cardiac disease. Arch Neurol. 1998 Jun;55(6):857-60. doi: 10.1001/archneur.55.6.857.
- Background: PubMed 12771269Woodruff BK, Britton JW, Tigaran S, Cascino GD, Burritt MF, McConnell JP, Ravkilde J, Molgaard H, Andreasen F, Dam M, Jaffe AS. Cardiac troponin levels following monitored epileptic seizures. Neurology. 2003 May 27;60(10):1690-2. doi: 10.1212/01.wnl.0000065881.46964.4f.
- Background: PubMed 12578934Tigaran S, Molgaard H, McClelland R, Dam M, Jaffe AS. Evidence of cardiac ischemia during seizures in drug refractory epilepsy patients. Neurology. 2003 Feb 11;60(3):492-5. doi: 10.1212/01.wnl.0000042090.13247.48.
- Background: PubMed 16844492Chin RF, Neville BG, Peckham C, Bedford H, Wade A, Scott RC; NLSTEPSS Collaborative Group. Incidence, cause, and short-term outcome of convulsive status epilepticus in childhood: prospective population-based study. Lancet. 2006 Jul 15;368(9531):222-9. doi: 10.1016/S0140-6736(06)69043-0.
- Background: PubMed 11918461Mitchell WG. Status epilepticus and acute serial seizures in children. J Child Neurol. 2002 Jan;17 Suppl 1:S36-43. doi: 10.1177/08830738020170010501.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Convulsive Status EPILEPTICUS, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christin Emad, resident (01281872843, christinemadragheb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac injury and convulsive status epilepticus (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119919, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.