Post-stroke Seizure and Epilepsy Following Thrombolytic Therapy

NCT06812000 | Completed DMC

• 1 other identifier: 17989
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Factors related to post-stroke seizure occurrence

  within 7 days following ischemic stroke onset

• Factors related to post-stroke epilepsy occurrence

  1 to 7 years following ischemic stroke onset

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of ischemic stroke
• Treatment with IV alteplase

You may not qualify if:

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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Mazandaran University of Medical Sciences

Sari, Mazandaran, Iran

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of neurology

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 6, 2025
• Study Start: April 14, 2024
• Primary Completion: January 12, 2025
• Study Completion: January 12, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-01

Locations

IR (1)