Comparison Study of Electrocardiogram Indexes in Patients With Epilepsy, Patients With First Seizure and Normal Population
September 20, 2024 updated by: Nasim Tabrizi, Mazandaran University of Medical Sciences
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mazandaran
-
Sari, Mazandaran, Iran, Islamic Republic of
- Mazandaran University of medical sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria for group 1:
- History of epilepsy for at least 2 years
- Taking antiseizure medications
Inclusion Criteria for group 2:
- Solid history of first seizure confirmed by a neurologist
Inclusion Criteria for group 3:
- No history of seizure
Exclusion Criteria:
- History of known cardiac disease or medical condition precipitating cardiac disease
- Electrolyte imbalance Taking medications with significant effect on ECG indexes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with epilepsy
Patients with epilepsy who experienced a recent generalized tonic-clonic seizure
|
12-lead electrocardiography
|
|
Patients with first seizure
Patients who experienced a recent generalized tonic-clonic seizure without any previous history
|
12-lead electrocardiography
|
|
Normal population
Participants without history of seizure or epilepsy
|
12-lead electrocardiography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The ECG in group 1 and 2 was performed for patients who were admitted within 24 hours of seizure occurrence
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2023
Primary Completion (Actual)
March 21, 2024
Study Completion (Actual)
August 10, 2024
Study Registration Dates
First Submitted
September 13, 2024
First Submitted That Met QC Criteria
September 20, 2024
First Posted (Actual)
September 23, 2024
Study Record Updates
Last Update Posted (Actual)
September 23, 2024
Last Update Submitted That Met QC Criteria
September 20, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15028 (Other Identifier: Mazandaran University of Medical Sciences)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
If needed based on request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.