Post-stroke Seizure and Epilepsy Following Thrombolytic Therapy

Investigation of Incidence Rate of Post-stroke Seizure and Post-stroke Epilepsy in Patients Under Treatment With Alteplase and Correlated Factors

This retrospective cohort study was conducted by reviewing the records of consecutive patients referred to Bu Ali Sina Hospital from 2016 to 2023, who were hospitalized with a diagnosis of ischemic stroke. The records of all patients treated with intravenous alteplase during the above period were extracted, and the relevant characteristics were recorded in a questionnaire. In each year, patients with ischemic stroke who were not treated with alteplase but were hospitalized at the Bu Ali Center were selected in a similar number to patients who received alteplase in the same year, and the relevant information was extracted from their records and recorded in a questionnaire. The incidence of post-stroke seizures and epilepsy was determined in both groups, and the factors associated with their incidence were studied and compared.

Study Overview

• Status: Completed
• Conditions: Thrombolytic (t-PA) Treatment; Post-stroke Seizure; Post-stroke Epilepsy

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Mazandaran
    • Sari, Mazandaran, Iran, Islamic Republic of
      • Mazandaran University of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with ischemic stroke who were admitted between 2016 and 2023 in Bu Ali Sina hospital

Description

Inclusion Criteria:

• Diagnosis of ischemic stroke
• Treatment with IV alteplase

Exclusion Criteria:

• History of epilepsy
• Taking antiseizure medications
• Unavailable patients
• Unreliability of recorded patients' files

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with ischemic stroke who received alteplase; Patients with ischemic stroke who received thrombolytic therapy with alteplase
Patients with ischemic stroke who did not receive alteplase; Patients with ischemic stroke who did not receive thrombolytic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of post-stroke seizure	Incidence rate of post-stroke seizure in patients who received alteplase compared to patients who did not receive alteplase.	within 7 days following ischemic stroke onset
Incidence rate of post-stroke epilepsy	Incidence rate of post-stroke epilepsy in patients who received alteplase compared to patients who did not receive alteplase.	1 to 7 years following ischemic stroke onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors related to post-stroke seizure occurrence	Demographic factors are registered in the questionnaire based on the patients' files. The severity of ischemic stroke is determined by the National Institutes of Health Stroke Scale (NIHSS). Brain CT findings including territory of infarct, cortical involvement and hemorrhagic transformation are investigated by reviewing the CT scans and recording the results in the questionnaire. Correlation of each mentioned factor with post-stroke seizure occurrence will be assessed using statistical methods.	within 7 days following ischemic stroke onset
Factors related to post-stroke epilepsy occurrence	Demographic factors are registered in the questionnaire based on the patients' files. The severity of ischemic stroke is determined by the National Institutes of Health Stroke Scale (NIHSS). Brain CT findings including territory of infarct, cortical involvement and hemorrhagic transformation are investigated by reviewing the CT scans and recording the results in the questionnaire. Correlation of each mentioned factor with post-stroke epilepsy occurrence will be assessed using statistical methods.	1 to 7 years following ischemic stroke onset

Collaborators and Investigators

• Sponsor: Mazandaran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2024
• Primary Completion (Actual): January 12, 2025
• Study Completion (Actual): January 12, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Epilepsy; Seizures
• Other Study ID Numbers: 17989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No