Patients With EpilepsyNCT06608784
Comparison Study of Electrocardiogram Indexes in Patients With Epilepsy, Patients With First Seizure and Normal Population
An observational study of Patients With Epilepsy and Patients With First Seizure, run by Mazandaran University of Medical Sciences at 1 site in Iran.
Trial summary
According to recent advances in epileptic heart and sudden unexplained death in epilepsy, in this study the investigators aimed to compare ECG findings in patients with epilepsy, patients who had experienced their first seizure and patients without history of seizure. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Epilepsy, Patients With First Seizure, Normal Population
- What is being tested?
- Electrocardiography
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- 21 Mar 2023to 10 Aug 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three groups enrolled the study. The first group: Patients with epilepsy who experienced a generalized tonic-clonic seizure within 24 hours before admission. The second group: Patients who experienced a first time generalized tonic-clonic seizure within 24 hours before admission. The third group: Patients without a history of generalized tonic-clonic seizure.
Who may be able to join
- History of epilepsy for at least 2 years
- Taking antiseizure medications
- Solid history of first seizure confirmed by a neurologist
- No history of seizure
Who cannot join
- History of known cardiac disease or medical condition precipitating cardiac disease
- Electrolyte imbalance Taking medications with significant effect on ECG indexes
Trial locations and contacts
1 site in 1 country.
About this study
According to recent advances in epileptic heart and sudden unexplained death in epilepsy, in this study the investigators aimed to compare ECG findings in patients with epilepsy, patients who had experienced their first seizure and patients without history of seizure.
- Being tested
- Electrocardiography
- Keywords
- Electrocardiogram, Epilepsy, Seizure
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiographyDiagnostic test
12-lead electrocardiography
| Study group | Role | What they receive |
|---|---|---|
| Patients with epilepsy | Patients with epilepsy who experienced a recent generalized tonic-clonic seizure Receives: Diagnostic Test: Electrocardiography | |
| Patients with first seizure | Patients who experienced a recent generalized tonic-clonic seizure without any previous history Receives: Diagnostic Test: Electrocardiography | |
| Normal population | Participants without history of seizure or epilepsy Receives: Diagnostic Test: Electrocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between ECG indexes in study groups
Analysis and comparing ECG indexes in study groups
Measured: The ECG in group 1 and 2 was performed for patients who were admitted within 24 hours of seizure occurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start21 Mar 2023
- Primary completion21 Mar 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With EpilepsyStudies of the same condition, open and under way.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasim Tabrizi, Mazandaran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608784
- Sponsor's protocol ID
- 15028
- Other IDs
- 15028
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If needed based on request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Electrocardiogram Indexes in Patients With Epilepsy, Patients With First Seizure and Normal Population
- ClinicalTrials.gov ID
- NCT06608784
- Acronym / sponsor ID
- 15028
- Keywords
- Electrocardiogram, Epilepsy, Seizure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 23 Sep 2024 (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.
According to recent advances in epileptic heart and sudden unexplained death in epilepsy, in this study the investigators aimed to compare ECG findings in patients with epilepsy, patients who had experienced their first seizure and patients without history of seizure.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with epilepsy | – | Diagnostic Test: ElectrocardiographyPatients with epilepsy who experienced a recent generalized tonic-clonic seizure |
| Patients with first seizure | – | Diagnostic Test: ElectrocardiographyPatients who experienced a recent generalized tonic-clonic seizure without any previous history |
| Normal population | – | Diagnostic Test: ElectrocardiographyParticipants without history of seizure or epilepsy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three groups enrolled the study. The first group: Patients with epilepsy who experienced a generalized tonic-clonic seizure within 24 hours before admission. The second group: Patients who experienced a first time generalized tonic-clonic seizure within 24 hours before admission. The third group: Patients without a history of generalized tonic-clonic seizure.
Key inclusion criteria (4 listed)
- History of epilepsy for at least 2 years
- Taking antiseizure medications
- Solid history of first seizure confirmed by a neurologist
- No history of seizure
Key exclusion criteria (2 listed)
- History of known cardiac disease or medical condition precipitating cardiac disease
- Electrolyte imbalance Taking medications with significant effect on ECG indexes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocardiography12-lead electrocardiography | Diagnostic test | Normal population, Patients with epilepsy, Patients with first seizure |
Primary outcome
Differences between ECG indexes in study groups
Time frame: The ECG in group 1 and 2 was performed for patients who were admitted within 24 hours of seizure occurrence
Analysis and comparing ECG indexes in study groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Yes. If needed based on request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Epilepsy and Patients With First Seizure, run by Mazandaran University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between ECG indexes in study groups (time frame: The ECG in group 1 and 2 was performed for patients who were admitted within 24 hours of seizure occurrence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.