Post-stroke SeizureNCT06812000
Post-stroke Seizure and Epilepsy Following Thrombolytic Therapy
An observational study of Post-stroke Seizure and Post-stroke Epilepsy, run by Mazandaran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Seizure, Post-stroke Epilepsy, Thrombolytic (t-PA) Treatment
- How many people
- 199 participants
- Where
- 1 siteIran
- Study dates
- 14 Apr 2024to 12 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic stroke who were admitted between 2016 and 2023 in Bu Ali Sina hospital
Who may be able to join
- Diagnosis of ischemic stroke
- Treatment with IV alteplase
Who cannot join
- History of epilepsy
- Taking antiseizure medications
- Unavailable patients
- Unreliability of recorded patients' files
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 to 7 years following ischemic stroke onset
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 to 7 years following ischemic stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start14 Apr 2024
- Primary completion12 Jan 2025
- Study completion12 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasim Tabrizi, Mazandaran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812000
- Sponsor's protocol ID
- 17989
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Incidence Rate of Post-stroke Seizure and Post-stroke Epilepsy in Patients Under Treatment With Alteplase and Correlated Factors
- ClinicalTrials.gov ID
- NCT06812000
- Acronym / sponsor ID
- 17989
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 12 Jan 2025 (actual)
- Study completion
- 12 Jan 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke who were admitted between 2016 and 2023 in Bu Ali Sina hospital
Key inclusion criteria (2 listed)
- Diagnosis of ischemic stroke
- Treatment with IV alteplase
Key exclusion criteria (4 listed)
- History of epilepsy
- Taking antiseizure medications
- Unavailable patients
- Unreliability of recorded patients' files
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Factors related to post-stroke seizure occurrence
Time frame: within 7 days following ischemic stroke onset
Factors related to post-stroke epilepsy occurrence
Time frame: 1 to 7 years following ischemic stroke onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-stroke Seizure and Post-stroke Epilepsy, run by Mazandaran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of post-stroke seizure (time frame: within 7 days following ischemic stroke onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.