Stroke, IschemicNCT06515392
TIA Scores' Mortality Predictions and Recurrent TIA and Stroke Prediction
An observational study of Stroke, Ischemic and Transient Ischemic Attack, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Our study adopts a prospective design. Our research aims to determine the significance of ABCD2, ABCD3-I, Canadian TIA Score, and NIHSS Score in predicting the likelihood of ischemic stroke within 30 days in patients presenting to the emergency department with transient ischemic attack (TIA) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Transient Ischemic Attack
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Jun 2025
- How long will I take part?
- 30 Days
- 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
- Adult, Older adult
Study population: patients over the age of 18 presenting to emergency department with symptoms of stroke and diagnosed with TIA will be enrolled to study and will be followed up for 30 days for recurrent TIA or stroke
Who may be able to join
- Patients presenting to the emergency department and diagnosed with TIA Patients diagnosed with ischemic stroke who did not receive thrombolytic therapy based on NIHSS score Patients aged 18 and above Patients who consented by signing the informed consent form
Who cannot join
- Patients diagnosed with hemorrhagic stroke Patients unwilling to participate in the study Patients with a history of trauma Patients unable to receive thrombolytic therapy for any reason (trauma, malignancy, etc.) Patients under the age of 18 Patients transferred from another hospital Patients who experienced cardiac arrest Patients who died for any reason other than ischemic stroke within 30 days Patients wishing to withdraw from the study at any time during the study period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, Yenimahalle, 06170
gulsen akcay, ass. prof., +905052874949, gulakcay@yahoo.com.tr
tugba sanalp menekse, specialist
About this study
Official title: The Role of TIA Scores and NIHSS Score in Predicting Early and Late Ischemic Stroke Risk in Patients Presenting With Transient Ischemic Attack to the Emergency Department
Our study adopts a prospective design. Our research aims to determine the significance of ABCD2, ABCD3-I, Canadian TIA Score, and NIHSS Score in predicting the likelihood of ischemic stroke within 30 days in patients presenting to the emergency department with transient ischemic attack (TIA)
Read the detailed description
Our study is planned as follows: Patients diagnosed with transient ischemic attack (TIA) presenting to the emergency department will undergo scoring by researchers, although they will not intervene the treatment process of the patients. Patients will be contacted by researchers or their families to ascertain whether they experience a recurrent stroke or TIA within 30 days, and their current health status will be assessed. The collected information will be recorded.
The study will include patients diagnosed with transient ischemic attack (TIA) based on tests and imaging conducted at Ankara Etlik City Hospital's emergency department. The planned duration for data collection and analysis is one year.
Parameters to be examined:
Age Gender Physical examination findings Comorbidities (hypertension, coronary artery disease, valvular heart disease, COPD, asthma, diabetes, others) Neurological examination findings Time of symptom onset Admission status (intensive care unit / ward) Findings from ultrasound, computed tomography, and MRI imaging Length of hospital stay Mortality (yes/no)
We aim to collect data from approximately 300 patients within the course of one year for our study
- Conditions
- Stroke, Ischemic, Transient Ischemic Attack
- Keywords
- transient ischemic attack, ischemic stroke, TIA scores
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
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 |
|---|---|---|
| TIA group | patients presenting with transient ischemic attack will be recorded and TIA scores and NIHSS score will be calculated, after 30 days follow-up, recurrent TIA and stroke rates will be determined |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent TIA or stroke
recurrent TIA within 30 days of follow-up
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Responsible party
- Sponsor
- Investigators
- gulsen akcay, ass. prof., Study director, ass. prof. of organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515392
- Sponsor's protocol ID
- TIA Scores and Mortality
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perry JJ, Losier JH, Stiell IG, Sharma M, Abdulaziz K. National survey of emergency physicians for transient ischemic attack (TIA) risk stratification consensus and appropriate treatment for a given level of risk. CJEM. 2016 Jan;18(1):10-8. doi: 10.1017/cem.2015.57. Epub 2015 Jul 31.
PubMed 26226855Cortel-LeBlanc MA, Sharma M, Cortel-LeBlanc A, Sivilotti MLA, Emond M, Stiell IG, Stotts G, Lee J, Worster A, Morris J, Cheung KW, Jin AY, Oczkowski WJ, Sahlas DJ, Murray HE, Mackey A, Verreault S, Camden MC, Yip S, Teal P, Gladstone DJ, Boulos MI, Chagnon N, Shouldice E, Atzema C, Slaoui T, Teitelbaum J, Abdulaziz KE, Wells GA, Taljaard M, Perry JJ. Predictors of neurologists confirming or overturning emergency physicians' diagnosis of TIA or stroke. CJEM. 2021 Nov;23(6):812-819. doi: 10.1007/s43678-021-00181-0. Epub 2021 Sep 1.
PubMed 34468970Yang C, Jin A, Lin J, Wang Y, Xu J, Meng X. Validation of the Canadian TIA Score to Predict Subsequent Stroke Risk in Chinese TIA Patients. Cerebrovasc Dis. 2022;51(6):735-743. doi: 10.1159/000524264. Epub 2022 May 5.
PubMed 35512630
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of TIA Scores and NIHSS Score in Predicting Early and Late Ischemic Stroke Risk in Patients Presenting With Transient Ischemic Attack to the Emergency Department
- ClinicalTrials.gov ID
- NCT06515392
- Acronym / sponsor ID
- TIA Scores and Mortality
- Conditions
- Stroke, Ischemic, Transient Ischemic Attack
- Keywords
- transient ischemic attack, ischemic stroke, TIA scores
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
Our study adopts a prospective design. Our research aims to determine the significance of ABCD2, ABCD3-I, Canadian TIA Score, and NIHSS Score in predicting the likelihood of ischemic stroke within 30 days in patients presenting to the emergency department with transient ischemic attack (TIA)
Detailed description
Our study is planned as follows: Patients diagnosed with transient ischemic attack (TIA) presenting to the emergency department will undergo scoring by researchers, although they will not intervene the treatment process of the patients. Patients will be contacted by researchers or their families to ascertain whether they experience a recurrent stroke or TIA within 30 days, and their current health status will be assessed. The collected information will be recorded.
The study will include patients diagnosed with transient ischemic attack (TIA) based on tests and imaging conducted at Ankara Etlik City Hospital's emergency department. The planned duration for data collection and analysis is one year.
Parameters to be examined:
Age Gender Physical examination findings Comorbidities (hypertension, coronary artery disease, valvular heart disease, COPD, asthma, diabetes, others) Neurological examination findings Time of symptom onset Admission status (intensive care unit / ward) Findings from ultrasound, computed tomography, and MRI imaging Length of hospital stay Mortality (yes/no)
We aim to collect data from approximately 300 patients within the course of one year for our study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIA group | – | –patients presenting with transient ischemic attack will be recorded and TIA scores and NIHSS score will be calculated, after 30 days follow-up, recurrent TIA and stroke rates will be determined |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients over the age of 18 presenting to emergency department with symptoms of stroke and diagnosed with TIA will be enrolled to study and will be followed up for 30 days for recurrent TIA or stroke
Key inclusion criteria (1 listed)
- Patients presenting to the emergency department and diagnosed with TIA Patients diagnosed with ischemic stroke who did not receive thrombolytic therapy based on NIHSS score Patients aged 18 and above Patients who consented by signing the informed consent form
Key exclusion criteria (1 listed)
- Patients diagnosed with hemorrhagic stroke Patients unwilling to participate in the study Patients with a history of trauma Patients unable to receive thrombolytic therapy for any reason (trauma, malignancy, etc.) Patients under the age of 18 Patients transferred from another hospital Patients who experienced cardiac arrest Patients who died for any reason other than ischemic stroke within 30 days Patients wishing to withdraw from the study at any time during the study period
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
recurrent TIA or stroke
Time frame: 30 days
recurrent TIA within 30 days of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 26226855Perry JJ, Losier JH, Stiell IG, Sharma M, Abdulaziz K. National survey of emergency physicians for transient ischemic attack (TIA) risk stratification consensus and appropriate treatment for a given level of risk. CJEM. 2016 Jan;18(1):10-8. doi: 10.1017/cem.2015.57. Epub 2015 Jul 31.
- Background: PubMed 34468970Cortel-LeBlanc MA, Sharma M, Cortel-LeBlanc A, Sivilotti MLA, Emond M, Stiell IG, Stotts G, Lee J, Worster A, Morris J, Cheung KW, Jin AY, Oczkowski WJ, Sahlas DJ, Murray HE, Mackey A, Verreault S, Camden MC, Yip S, Teal P, Gladstone DJ, Boulos MI, Chagnon N, Shouldice E, Atzema C, Slaoui T, Teitelbaum J, Abdulaziz KE, Wells GA, Taljaard M, Perry JJ. Predictors of neurologists confirming or overturning emergency physicians' diagnosis of TIA or stroke. CJEM. 2021 Nov;23(6):812-819. doi: 10.1007/s43678-021-00181-0. Epub 2021 Sep 1.
- Background: PubMed 35512630Yang C, Jin A, Lin J, Wang Y, Xu J, Meng X. Validation of the Canadian TIA Score to Predict Subsequent Stroke Risk in Chinese TIA Patients. Cerebrovasc Dis. 2022;51(6):735-743. doi: 10.1159/000524264. Epub 2022 May 5.
- Individual participant dataSharing planned: No
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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.
gulsen akcay, ass. prof. study director
ass. prof. of organization
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 Stroke, Ischemic and Transient Ischemic Attack, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gulsen akcay, ass. prof. (+905052874949, gulakcay@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent TIA or stroke (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515392, which also lists 3 linked publications.
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 23 Jul 2024.