AzTrials
AzTrials

ECG ChangesNCT07135713

Electrocardiographic Changes Associated With Epilepsy

An observational study of ECG Changes, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Samaan Rezk Gad El kariem, Master contact

0 12 21103532

samaan.17289895@med.aun.edu.eg

Eman Fathallah Gad, Professor contact

0111519115 8

Emnangad2019@med.aun.edu.eg

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.

  1. 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.

  1. First posted22 Aug 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

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)
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 34215386
  • Ibrahim 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 35204843
  • Bastos F, Cross JH. Epilepsy. Handb Clin Neurol. 2020;174:137-158. doi: 10.1016/B978-0-444-64148-9.00011-9.

    PubMed 32977874

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.

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