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

Conditions

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

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
Diagnostic test: Electrocardiography
12-lead electrocardiography
Patients with first seizure
Patients who experienced a recent generalized tonic-clonic seizure without any previous history
Diagnostic test: Electrocardiography
12-lead electrocardiography
Normal population
Participants without history of seizure or epilepsy
Diagnostic test: Electrocardiography
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.

Sponsor

Mazandaran University of Medical Sciences

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.

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