Comparison Study of Electrocardiogram Indexes in Patients With Epilepsy, Patients With First Seizure and Normal Population

NCT06608784 | Completed DMC

• 1 other identifier: 15028
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patients With Epilepsy; Patients With First Seizure; Normal Population

Keywords

Electrocardiogram; Epilepsy; Seizure

Outcome Measures

Primary Outcomes (1)

• Differences between ECG indexes in study groups

  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

Study Arms (3)

Patients with epilepsy

Patients with epilepsy who experienced a recent generalized tonic-clonic seizure

Diagnostic Test: Electrocardiography

Patients with first seizure

Patients who experienced a recent generalized tonic-clonic seizure without any previous history

Diagnostic Test: Electrocardiography

Normal population

Participants without history of seizure or epilepsy

Diagnostic Test: Electrocardiography

Interventions

Electrocardiography DIAGNOSTIC_TEST

12-lead electrocardiography

Normal population; Patients with epilepsy; Patients with first seizure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• History of epilepsy for at least 2 years
• Taking antiseizure medications
• \- Solid history of first seizure confirmed by a neurologist
• \- No history of seizure

You may not qualify if:

• History of known cardiac disease or medical condition precipitating cardiac disease
• Electrolyte imbalance Taking medications with significant effect on ECG indexes

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Mazandaran University of Medical Sciences

Sari, Mazandaran, Iran

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 23, 2024
• Study Start: March 21, 2023
• Primary Completion: March 21, 2024
• Study Completion: August 10, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IR (1)