ECG ChangesNCT07135713
Electrocardiographic Changes Associated With Epilepsy
An observational study of ECG Changes, run by Assiut University.
Trial summary
Identify and characterize electrocardiographic (ECG) changes occurring during the post-ictal phase of epileptic seizures. Evaluate the duration and severity of post-ictal ECG abnormalities. Assess the correlation between ECG changes and seizure type, duration, and severity. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- ECG Changes
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 year to 18 years
- All sexes
- Child, Adult
Study population: Eighty (80) children with epilepsy will be included in this study during the period from October 2025 to October 2026. Sample size was calculated by Open Epi Info version 3
Who may be able to join
- Children from 1 year to 18 year are diagnosed with epilepsy.
- Routine EEG.
Who cannot join
- Known pre-existing cardiac conditions e.g arrhythmias, heart failure.
- Current use of medications significantly affecting ECG.
- Other causes of convulsion:hypoglycemia,hypernatriemia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Electrocardiographic Changes Associated With Epilepsy in Children Attending Assiut University Children's Hospital
Identify and characterize electrocardiographic (ECG) changes occurring during the post-ictal phase of epileptic seizures. Evaluate the duration and severity of post-ictal ECG abnormalities. Assess the correlation between ECG changes and seizure type, duration, and severity. Explore the association of ECG changes with patient demographics
Read the detailed description
Epilepsy is a chronic disease triggered by increased impulsiveness of nerve cells in the brain and may require a lifelong treatment. Epilepsy is confirmed by two or more unprovoked seizures in more than 24 hours, Febrile Convulsion (FC) is another type of seizure occurring due to fever over 38 °C without a history of convulsion, CNS infection, electrolyte imbalance, metabolic disorder, intoxication, and trauma
. Epilepsy is one of the most common neurological conditions which occurs in approximately 0.5-1% of children worldwide. However, it is not a disease entity but a syndrome of symptoms that can occur against various morphological and metabolic changes in the brain. One of the symptoms of epilepsy is epileptic seizures, i.e., temporary bioelectrical disturbances in the nerve cells of the brain . The simplified classification of epileptic seizures distinguishes between generalized seizures and partial (focal) seizures, depending, among other things, on the area of the brain where the discharges occur. Determination of the epileptic syndrome, i.e., the specific set of seizure types and electroencephalographic and imaging features, is the final stage of diagnosis . The cause of epilepsy is very often not recognized, and for this reason the diagnosis should be based on a thorough history of the patient, witnesses to the seizures, electroencephalogram (EEG) studies, and structural and functional neuroimaging of the central nervous system . One of the most dangerous changes occurs due to epileptic seizures are cardiovascular changes, which may result in sudden unexpected death in epileptic patients. Moreover, seizure leads to disturbance in cardiac functions and resulting in syncopal events, notablygeneralized convulsive seizures, put the cardiovascular system on strain, which may promote cardiac complications such as cardiac arrhythmias, cardiomyopathy, and myocardial infarction . A significant proportion of patients saw a rise in cardiac necrosis and dysfunction indicators after protracted convulsions, which might signal the beginning of myocardial damage Relevant abnormalities like prolonged QTc interval or cardiac block can be detected by a 12-lead ECG, which is an inexpensive test. Hypocalcemia as a cause of convulsions can be identified on an electrocardiogram (ECG) by a QTc prolongation due to a ST segment elongation, the severity of which is inversely related to the serum calcium level . Electrocardiographic changes in patients with drug-resistant epilepsy discovered that patients with epilepsy had significantly longer mean PR intervals, shorter mean QRS durations, shorter mean QTc intervals, and longer corrected QT interval dispersion than subjects without epilepsy . Cardiac electrical and functional abnormalities also have been described in children with epilepsy suggesting that the epileptic heart may affect pediatric patients. Implicit in the concept of the epileptic heart is that the epilepsy chronicity may be associated with an increased risk of developing cardiovascular complications. To date, only a few studies with small numbers of patients or highly selective populations have demonstrated the associations between cardiac alterations and longstanding epilepsy . ECG changes are commonly observed in epilepsy which make ECG a promising candidate to monitor seizure risk. Most ECG research in this domain has focused on heart rate-related changes. However, several studies have identified a range of other peri-ictal ECG parameter changesthat may potentially prove useful for seizure detection and forecasting.
- Conditions
- ECG Changes
What is being measured
The primary outcome is the main question the study is designed to answer.
Out come measure
Title: Prevalence of Post-Ictal Electrocardiographic (ECG) Abnormalities Description: The proportion of participants who experience post-ictal ECG abnormalities, including sinus tachycardia, bradycardia, QT/QTc interval changes, ST-T segment changes, atrial/ventricular ectopy, or conduction blocks. Assessment will be performed using a standard 12-lead electrocardiogram (ECG).
Unit of Measure: Percentage of participants
Measured: Baseline (immediate post-ictal phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ECG ChangesStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaan Rezk Gad El Kariem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135713
- Sponsor's protocol ID
- Electrocardiographic Changes
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Katyayan A, Diaz-Medina G. Epilepsy: Epileptic Syndromes and Treatment. Neurol Clin. 2021 Aug;39(3):779-795. doi: 10.1016/j.ncl.2021.04.002.
PubMed 34215386Ibrahim A, Megahed A, Salem A, Zekry O. Impact of Cardiac Injury on the Clinical Outcome of Children with Convulsive Status Epilepticus. Children (Basel). 2022 Jan 18;9(2):122. doi: 10.3390/children9020122.
PubMed 35204843Bastos F, Cross JH. Epilepsy. Handb Clin Neurol. 2020;174:137-158. doi: 10.1016/B978-0-444-64148-9.00011-9.
PubMed 32977874
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiographic Changes Associated With Epilepsy in Children Attending Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT07135713
- Acronym / sponsor ID
- Electrocardiographic Changes
- Conditions
- ECG Changes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 Aug 2025 (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.
Identify and characterize electrocardiographic (ECG) changes occurring during the post-ictal phase of epileptic seizures. Evaluate the duration and severity of post-ictal ECG abnormalities. Assess the correlation between ECG changes and seizure type, duration, and severity. Explore the association of ECG changes with patient demographics
Detailed description
Epilepsy is a chronic disease triggered by increased impulsiveness of nerve cells in the brain and may require a lifelong treatment. Epilepsy is confirmed by two or more unprovoked seizures in more than 24 hours, Febrile Convulsion (FC) is another type of seizure occurring due to fever over 38 °C without a history of convulsion, CNS infection, electrolyte imbalance, metabolic disorder, intoxication, and trauma
. Epilepsy is one of the most common neurological conditions which occurs in approximately 0.5-1% of children worldwide. However, it is not a disease entity but a syndrome of symptoms that can occur against various morphological and metabolic changes in the brain. One of the symptoms of epilepsy is epileptic seizures, i.e., temporary bioelectrical disturbances in the nerve cells of the brain . The simplified classification of epileptic seizures distinguishes between generalized seizures and partial (focal) seizures, depending, among other things, on the area of the brain where the discharges occur. Determination of the epileptic syndrome, i.e., the specific set of seizure types and electroencephalographic and imaging features, is the final stage of diagnosis . The cause of epilepsy is very often not recognized, and for this reason the diagnosis should be based on a thorough history of the patient, witnesses to the seizures, electroencephalogram (EEG) studies, and structural and functional neuroimaging of the central nervous system . One of the most dangerous changes occurs due to epileptic seizures are cardiovascular changes, which may result in sudden unexpected death in epileptic patients. Moreover, seizure leads to disturbance in cardiac functions and resulting in syncopal events, notablygeneralized convulsive seizures, put the cardiovascular system on strain, which may promote cardiac complications such as cardiac arrhythmias, cardiomyopathy, and myocardial infarction . A significant proportion of patients saw a rise in cardiac necrosis and dysfunction indicators after protracted convulsions, which might signal the beginning of myocardial damage Relevant abnormalities like prolonged QTc interval or cardiac block can be detected by a 12-lead ECG, which is an inexpensive test. Hypocalcemia as a cause of convulsions can be identified on an electrocardiogram (ECG) by a QTc prolongation due to a ST segment elongation, the severity of which is inversely related to the serum calcium level . Electrocardiographic changes in patients with drug-resistant epilepsy discovered that patients with epilepsy had significantly longer mean PR intervals, shorter mean QRS durations, shorter mean QTc intervals, and longer corrected QT interval dispersion than subjects without epilepsy . Cardiac electrical and functional abnormalities also have been described in children with epilepsy suggesting that the epileptic heart may affect pediatric patients. Implicit in the concept of the epileptic heart is that the epilepsy chronicity may be associated with an increased risk of developing cardiovascular complications. To date, only a few studies with small numbers of patients or highly selective populations have demonstrated the associations between cardiac alterations and longstanding epilepsy . ECG changes are commonly observed in epilepsy which make ECG a promising candidate to monitor seizure risk. Most ECG research in this domain has focused on heart rate-related changes. However, several studies have identified a range of other peri-ictal ECG parameter changesthat may potentially prove useful for seizure detection and forecasting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Eighty (80) children with epilepsy will be included in this study during the period from October 2025 to October 2026. Sample size was calculated by Open Epi Info version 3
Key inclusion criteria (2 listed)
- Children from 1 year to 18 year are diagnosed with epilepsy.
- Routine EEG.
Key exclusion criteria (3 listed)
- Known pre-existing cardiac conditions e.g arrhythmias, heart failure.
- Current use of medications significantly affecting ECG.
- Other causes of convulsion:hypoglycemia,hypernatriemia.
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
Out come measure
Time frame: Baseline (immediate post-ictal phase)
Title: Prevalence of Post-Ictal Electrocardiographic (ECG) Abnormalities Description: The proportion of participants who experience post-ictal ECG abnormalities, including sinus tachycardia, bradycardia, QT/QTc interval changes, ST-T segment changes, atrial/ventricular ectopy, or conduction blocks. Assessment will be performed using a standard 12-lead electrocardiogram (ECG). Unit of Measure: Percentage of participants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 34215386Katyayan A, Diaz-Medina G. Epilepsy: Epileptic Syndromes and Treatment. Neurol Clin. 2021 Aug;39(3):779-795. doi: 10.1016/j.ncl.2021.04.002.
- Background: PubMed 35204843Ibrahim A, Megahed A, Salem A, Zekry O. Impact of Cardiac Injury on the Clinical Outcome of Children with Convulsive Status Epilepticus. Children (Basel). 2022 Jan 18;9(2):122. doi: 10.3390/children9020122.
- Background: PubMed 32977874Bastos F, Cross JH. Epilepsy. Handb Clin Neurol. 2020;174:137-158. doi: 10.1016/B978-0-444-64148-9.00011-9.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ECG Changes, 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 3 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: opening soon, as of the sponsor's last update on 22 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samaan Rezk Gad El kariem, Master (0 12 21103532, samaan.17289895@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Out come measure (time frame: Baseline (immediate post-ictal phase)). 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 NCT07135713, which also lists 3 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 22 Aug 2025.