Stroke, IschemicRAV-TUNNCT05325606
Registry-based Stroke in Tunisia
An observational study of Stroke, Ischemic and Strokes Thrombotic, run by University of Monastir at 1 site in Tunisia.
Trial summary
Study the prevalence of strokes in the emergency department (ED) and their possible eligibility for thrombolysis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Ischemic, Strokes Thrombotic, Stroke
- How many people
- 800 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jun 2020to 1 Jan 2025
- How long will I take part?
- 1 Year
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with stroke symptoms and accept to enroll the study .
Who may be able to join
- All patients with stroke symptoms.
Who cannot join
- Refusal of inclusion
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Nouira Semir
Monastir, 5060
Nouira Semir, Professor, 73106046, semir.nouira@rns.tn
About this study
Official title: Registry-based Stroke Research in Tunisia: Multicenter Study
Study the prevalence of strokes in the emergency department (ED) and their possible eligibility for thrombolysis.
Read the detailed description
The diagnosis and management of strokes represent a great emergency that requires multidisciplinary teams and an organization of the care chain from the collection of patients at the site of the stroke to follow-up care.
That is why it is necessary to identify the prevalence of stroke in the ED in Tunisia and to evaluate their eligibility for thrombolysis.
- Conditions
- Stroke, Ischemic, Strokes Thrombotic, Stroke
- Keywords
- stroke, thrombolysis, Tunisia
- Medical subject headings
- Ischemic Stroke, Thrombotic Stroke, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke prevalence
After entering the ED , the patient will have a radiological and biological screening to establish his right diagnostic and then we have stroke prevalence in the ED.
Measured: 1day
Modified Rankin Scale (MRS) score change
After discharge from ED, patients were called back in order to know information about the quality of life and the search for persistent complications.
Measured: After a month , six month , 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Jun 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325606
- Sponsor's protocol ID
- Tunisia Stroke
- Acronym
- RAV-TUN
- Status last verified
- Nov 2023
- First submitted
- 14 Mar 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry-based Stroke Research in Tunisia: Multicenter Study
- ClinicalTrials.gov ID
- NCT05325606
- Acronym / sponsor ID
- RAV-TUN / Tunisia Stroke
- Conditions
- Stroke, Ischemic, Strokes Thrombotic, Stroke
- Keywords
- stroke, thrombolysis, Tunisia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 13 Apr 2022 (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.
Study the prevalence of strokes in the emergency department (ED) and their possible eligibility for thrombolysis.
Detailed description
The diagnosis and management of strokes represent a great emergency that requires multidisciplinary teams and an organization of the care chain from the collection of patients at the site of the stroke to follow-up care.
That is why it is necessary to identify the prevalence of stroke in the ED in Tunisia and to evaluate their eligibility for thrombolysis.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with stroke symptoms and accept to enroll the study .
Key inclusion criteria (1 listed)
- All patients with stroke symptoms.
Key exclusion criteria (1 listed)
- Refusal of inclusion
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
Stroke prevalence
Time frame: 1day
After entering the ED , the patient will have a radiological and biological screening to establish his right diagnostic and then we have stroke prevalence in the ED.
Modified Rankin Scale (MRS) score change
Time frame: After a month , six month , 1 year
After discharge from ED, patients were called back in order to know information about the quality of life and the search for persistent complications.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
Nouira Semir, Professor principal investigator
University of Monastir
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 Strokes Thrombotic, run by University of Monastir at 1 site in Tunisia.
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 28 Feb 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 Tunisia. 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 Nouira Semir, Professor (73106046 ext. +216, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke prevalence (time frame: 1day). 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 28 Feb 2024.