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OpenTrials
Completed

NCT Number: NCT06812000

Post-stroke Seizure and Epilepsy Following Thrombolytic Therapy

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.

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Key information

Conditions

Post-stroke Seizure Post-stroke Epilepsy Thrombolytic (t-PA) Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mazandaran University of Medical Sciences

Sari, Mazandaran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence rate of post-stroke seizure

    Time frame: within 7 days following ischemic stroke onset

    Incidence rate of post-stroke seizure in patients who received alteplase compared to patients who did not receive alteplase.

  2. Incidence rate of post-stroke epilepsy

    Time frame: 1 to 7 years following ischemic stroke onset

    Incidence rate of post-stroke epilepsy in patients who received alteplase compared to patients who did not receive alteplase.

Secondary outcomes

  1. Factors related to post-stroke seizure occurrence

    Time frame: within 7 days following ischemic stroke onset

    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.

  2. Factors related to post-stroke epilepsy occurrence

    Time frame: 1 to 7 years following ischemic stroke onset

    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.

Sponsors and collaborators

Lead sponsor

Mazandaran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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