Post-stroke Seizure and Epilepsy Following Thrombolytic Therapy

January 31, 2025 updated by: Nasim Tabrizi, Mazandaran University of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
199

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
within 7 days following ischemic stroke onset
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.
1 to 7 years following ischemic stroke onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
within 7 days following ischemic stroke onset
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.
1 to 7 years following ischemic stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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