- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06170034
Post-emergency Management of Patients With Transient Ischemic Attack
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marilyne Grinand, PhD
- Phone Number: (+33)432759392
- Email: grinand.marilyne@ch-avignon.fr
Study Locations
-
-
Provence-Alpes-Côte d'Azur
-
Avignon, Provence-Alpes-Côte d'Azur, France
- Recruiting
- Centre Hospitalier d'Avignon
-
Contact:
- Marilyne Grinand, PhD
- Phone Number: (+33)432759392
- Email: grinand.marilyne@ch-avignon.fr
-
Contact:
- Yohan Fouilhe, Medical Intern
- Email: fouilhe.yohan@ch-avignon.fr
-
Principal Investigator:
- Yohan Fouilhe, Medical Intern
-
Sub-Investigator:
- Ludovic Sauvage, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient over 18 years old.
- Consultation in the emergency department.
- Suspected TIA diagnosed by emergency physician.
- Duration of TIA symptoms <1 hour.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TIA patients
|
Satisfaction questionnaire to assess how TIA patients feels about their medical care.
Recording appointments and results of examinations and consultations in TIA management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess time between arrival in the emergency department for suspected TIA patients and MRI.
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time between arrival in the emergency department and MRI by departments.
Time Frame: Baseline
|
Baseline
|
Time between arrival in the emergency department and MRI by ABCD² score.
Time Frame: Baseline
|
Baseline
|
Percentage of patients with complete TIA management by departments.
Time Frame: Baseline
|
Baseline
|
Hospitalization times according to care units
Time Frame: Baseline
|
Baseline
|
Hospitalization times according to complete TIA management
Time Frame: Baseline
|
Baseline
|
Percentage of patients with secondary event, according to complete TIA management
Time Frame: Baseline
|
Baseline
|
Number of outpatients without complete TIA management one month after TIA.
Time Frame: At 1 month follow-up
|
At 1 month follow-up
|
Patient satisfaction with a short questionnaire
Time Frame: At 1 month follow-up
|
At 1 month follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yohan Fouilhe, Medical Intern, Centre Hospitalier d'Avignon, Service des urgences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEC AIT 84
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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