Transient Ischemic AttackNCT06170034
Post-emergency Management of Patients With Transient Ischemic Attack
An observational study of Transient Ischemic Attack, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
Trial summary
A transient ischemic attack (TIA) is a momentary neurological dysfunction due to a brief cessation of blood flow to a region of the brain, resulting in typical signs of stroke (hemiplegia, aphasia, dysarthria), but whose clinical symptoms typically last less than an hour, with no visible lesion on imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischemic Attack
- What is being tested?
- Satisfaction questionnaire and Medical care questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2023to 16 Jun 2024
- 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 a diagnosis of TIA in the emergency department
Who may be able to join
- Patient over 18 years old.
- Consultation in the emergency department.
- Suspected TIA diagnosed by emergency physician.
- Duration of TIA symptoms <1 hour.
Who cannot join
- Validation MRI performed prior to suspected TIA.
- Patient hospitalized for a condition other than TIA, including stroke.
- Patient referred to another hospital for further examination.
- Pregnant women.
- Patient unable to understand and answer a questionnaire.
- Patient under legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
A transient ischemic attack (TIA) is a momentary neurological dysfunction due to a brief cessation of blood flow to a region of the brain, resulting in typical signs of stroke (hemiplegia, aphasia, dysarthria), but whose clinical symptoms typically last less than an hour, with no visible lesion on imaging. This diagnosis remains difficult and is essentially based on the clinical judgment of the physician.
Because a TIA can be a "pre-alarm" for stroke in 20-30% of cases, it needs to be treated appropriately and as early as possible in the emergency department. Stroke rates after untreated TIA are 5% within 48 hours, 10% within one month and 20% within one year. This risk is calculated using the ABCD² score which is based on the patient's risk factors and the clinical manifestations of TIA. Patients with a score ≥ 3 should be hospitalized as soon as possible for a complete medical evaluation. However, this score has not been scientifically validated, and several specialists agree that all TIAs should be evaluated immediately. Preventing stroke is a major public health issue because it is a serious, disabling and sometimes fatal disease. Given the seriousness of the progression from TIA to stroke, the French National Authority for Health has issued a series of management recommendations. However, in practice, these guidelines remain complicated to follow and patients management may vary and be more or less effective.
Therefore, the aim of this study is to highlight the differences in how inpatients and outpatients are managed. Following these observations, solutions will be sought to make the care and management of these patients more efficient and more in line with recommendations.
- Conditions
- Transient Ischemic Attack
- Being tested
- Satisfaction questionnaire, Medical care questionnaire
- Keywords
- Emergency, Cerebral RMI, Guidelines compliance
- Medical subject headings
- Ischemic Attack, Transient, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satisfaction questionnaireBehavioural
Satisfaction questionnaire to assess how TIA patients feels about their medical care.
Medical care questionnaireOther
Recording appointments and results of examinations and consultations in TIA management
| Study group | Role | What they receive |
|---|---|---|
| TIA patients | Not described Receives: Behavioral: Satisfaction questionnaire; Other: Medical care questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess time between arrival in the emergency department for suspected TIA patients and MRI.
Measured: Baseline
Secondary outcomes (8)
Time between arrival in the emergency department and MRI by departments.
Measured: Baseline
Time between arrival in the emergency department and MRI by ABCD² score.
Measured: Baseline
Percentage of patients with complete TIA management by departments.
Measured: Baseline
Hospitalization times according to care units
Measured: Baseline
Hospitalization times according to complete TIA management
Measured: Baseline
Percentage of patients with secondary event, according to complete TIA management
Measured: Baseline
Number of outpatients without complete TIA management one month after TIA.
Measured: At 1 month follow-up
Patient satisfaction with a short questionnaire
Measured: At 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start16 Nov 2023
- Primary completion16 May 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic AttackStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Duffaut - Avignon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yohan Fouilhe, Medical Intern, Principal investigator, Centre Hospitalier d'Avignon, Service des urgences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170034
- Sponsor's protocol ID
- PEC AIT 84
- Status last verified
- Jan 2025
- First submitted
- 17 Nov 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-emergency Management of Patients With Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT06170034
- Acronym / sponsor ID
- PEC AIT 84
- Conditions
- Transient Ischemic Attack
- Keywords
- Emergency, Cerebral RMI, Guidelines compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri Duffaut - AvignonUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 14 Dec 2023 (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.
A transient ischemic attack (TIA) is a momentary neurological dysfunction due to a brief cessation of blood flow to a region of the brain, resulting in typical signs of stroke (hemiplegia, aphasia, dysarthria), but whose clinical symptoms typically last less than an hour, with no visible lesion on imaging. This diagnosis remains difficult and is essentially based on the clinical judgment of the physician.
Because a TIA can be a "pre-alarm" for stroke in 20-30% of cases, it needs to be treated appropriately and as early as possible in the emergency department. Stroke rates after untreated TIA are 5% within 48 hours, 10% within one month and 20% within one year. This risk is calculated using the ABCD² score which is based on the patient's risk factors and the clinical manifestations of TIA. Patients with a score ≥ 3 should be hospitalized as soon as possible for a complete medical evaluation. However, this score has not been scientifically validated, and several specialists agree that all TIAs should be evaluated immediately. Preventing stroke is a major public health issue because it is a serious, disabling and sometimes fatal disease. Given the seriousness of the progression from TIA to stroke, the French National Authority for Health has issued a series of management recommendations. However, in practice, these guidelines remain complicated to follow and patients management may vary and be more or less effective.
Therefore, the aim of this study is to highlight the differences in how inpatients and outpatients are managed. Following these observations, solutions will be sought to make the care and management of these patients more efficient and more in line with recommendations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIA patients | – | Behavioral: Satisfaction questionnaire, Other: Medical care questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of TIA in the emergency department
Key inclusion criteria (4 listed)
- Patient over 18 years old.
- Consultation in the emergency department.
- Suspected TIA diagnosed by emergency physician.
- Duration of TIA symptoms <1 hour.
Key exclusion criteria (6 listed)
- Validation MRI performed prior to suspected TIA.
- Patient hospitalized for a condition other than TIA, including stroke.
- Patient referred to another hospital for further examination.
- Pregnant women.
- Patient unable to understand and answer a questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Satisfaction questionnaireSatisfaction questionnaire to assess how TIA patients feels about their medical care. | Behavioural | TIA patients |
| Medical care questionnaireRecording appointments and results of examinations and consultations in TIA management | Other | TIA patients |
Primary outcome
Assess time between arrival in the emergency department for suspected TIA patients and MRI.
Time frame: Baseline
8 secondary outcomes
Time between arrival in the emergency department and MRI by departments.
Time frame: Baseline
Time between arrival in the emergency department and MRI by ABCD² score.
Time frame: Baseline
Percentage of patients with complete TIA management by departments.
Time frame: Baseline
Hospitalization times according to care units
Time frame: Baseline
Hospitalization times according to complete TIA management
Time frame: Baseline
Percentage of patients with secondary event, according to complete TIA management
Time frame: Baseline
Number of outpatients without complete TIA management one month after TIA.
Time frame: At 1 month follow-up
Patient satisfaction with a short questionnaire
Time frame: At 1 month follow-up
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 30 Jan 2025.
- 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.
Yohan Fouilhe, Medical Intern principal investigator
Centre Hospitalier d'Avignon, Service des urgences
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 Transient Ischemic Attack, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
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 4 inclusion and 6 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 30 Jan 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 France. 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?
Assess time between arrival in the emergency department for suspected TIA patients and MRI. (time frame: Baseline). 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 30 Jan 2025.