NCT06170034

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2024

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

November 17, 2023

Last Update Submit

January 28, 2025

Conditions

Keywords

EmergencyCerebral RMIGuidelines compliance

Outcome Measures

Primary Outcomes (1)

  • Assess time between arrival in the emergency department for suspected TIA patients and MRI.

    Baseline

Secondary Outcomes (8)

  • Time between arrival in the emergency department and MRI by departments.

    Baseline

  • Time between arrival in the emergency department and MRI by ABCD² score.

    Baseline

  • Percentage of patients with complete TIA management by departments.

    Baseline

  • Hospitalization times according to care units

    Baseline

  • Hospitalization times according to complete TIA management

    Baseline

  • +3 more secondary outcomes

Study Arms (1)

TIA patients

Behavioral: Satisfaction questionnaireOther: Medical care questionnaire

Interventions

Satisfaction questionnaire to assess how TIA patients feels about their medical care.

TIA patients

Recording appointments and results of examinations and consultations in TIA management

TIA patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of TIA in the emergency department

You may qualify if:

  • Patient over 18 years old.
  • Consultation in the emergency department.
  • Suspected TIA diagnosed by emergency physician.
  • Duration of TIA symptoms \<1 hour.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier d'Avignon

Avignon, France

Location

MeSH Terms

Conditions

Ischemic Attack, TransientEmergencies

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yohan Fouilhe, Medical Intern

    Centre Hospitalier d'Avignon, Service des urgences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2023

First Posted

December 14, 2023

Study Start

November 16, 2023

Primary Completion

May 16, 2024

Study Completion

June 16, 2024

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations