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Transient Ischemic AttackAIT-AMBU-GRENCT05216198

Evaluation of the Effectiveness of a City Hospital Care Network for the Care of Patients With Transient Ischemic Accident (TIA)

An observational study of Transient Ischemic Attack, run by University Hospital, Grenoble at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Transient ischemic accidents (TIA) are a frequent resort to hospitalization in the emergency department and are serious events in terms of recurrence and handicap. The organization of the "TIA sector" at CHUGA aims to facilitate on the one hand the care of the patient during his hospitalization in the emergencies and… 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?
Check of the different exams performed at the emergencies
How many people
51 participants
Where
1 siteFrance
Study dates
7 Apr 2022to 1 Jul 2022
How long will I take part?
6 Months
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: Diagnostic of TIA by the exams performed in the emergencies of CHUGA.

Who may be able to join

  • Hospitalization in the Emergency Department of the CHUGA for suspicion of TIA
  • Possible or probable TIA diagnosis on discharge
  • Major patient
  • Outpatient care after emergency care

Who cannot join

  • Protected patient (guardianship, curatorship, people not affiliated with Social Security)
  • Patient deprived of liberty by a judicial or administrative decision
  • Patient hospitalized without consent under Articles L. 3212-1 and L. 3213-1 which does not fall under the provisions of Article L. 1121-8
  • Adult patient subject to a legal protection measure or unable to express consent
  • Pregnant, lactating or parturient women
  • Patient who does not speak French
  • Inability to answer the phone to answer questions
  • No attending physician

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • CHU Grenoble Alpes - Urgences

    Grenoble, 38100

    Vivien Brenckmann, Dr, 0476767575, vbrenckmann@chu-grenoble.fr

    Recruiting

Other trials in France

About this study

Transient ischemic accidents (TIA) are a frequent resort to hospitalization in the emergency department and are serious events in terms of recurrence and handicap. The organization of the "TIA sector" at CHUGA aims to facilitate on the one hand the care of the patient during his hospitalization in the emergencies and on the other hand to allow a safer discharge of the patient as well as his follow-up in ambulatory. The aim of this study is to study the feasibility of comprehensive short-term outpatient management after hospitalization in the emergencies. The research hypothesis is that 90% of patients complete all of the 10 recommended examinations for the diagnosis of TIA, analysis of its risk factors and initiation of necessary treatments, if necessary.

Read the detailed description

Current knowledge on pathology Transient ischemic accidents (TIA) are a frequent resort to hospitalization in the emergency department (378 visits in 2019 to the CHUGA emergencies, 340 in 2020, or about 1 entry for this reason per day) and are serious events in terms of recurrence and handicap. The risk of Cerebral Vascular Accident (stroke) is around 10% at 3 months after the first episode of TIA [1]. Standardizing care and improving patient compliance with treatment and monitoring of their pathology aims to reduce the recurrence and the occurrence of more serious consequences.

In 2021, the Northern Alpine Emergency Network (RENAU) published standardized care for all hospitals and clinics dependent on this network, based on the French recommendations of the Haute Autorité de Santé and the French Neurovascular Society (SFNV).

This care was put in place at the Emergency Department of the CHU Grenoble Alpes (CHUGA) in the form of an "TIA program" and defines the patient's journey when he presents signs compatible with the suspicion of TIA. In addition to being based on national and regional recommendations, this sector has been improved by providing a questionnaire to all Neuro-Vascular Units (NVU) in France.

The organization of the "TIA sector" at CHUGA aims to facilitate on the one hand the care of the patient during his hospitalization in the emergency room and on the other hand to allow a safer discharge of the patient as well as his follow-up in ambulatory.

For example, a Parisian study, carried out at the Bichat hospital [2], showed that a standardized treatment pathway for TIAs was linked to a reduction of more than 30% in the risk of stroke 3 months after the TIA.

On arrival at the Emergency Department, in the event of any suggestive signs, the patient is included in the "TIA sector". He is examined as quickly as possible by an emergency physician and / or the neurologist on call. A predefined biology is taken and an electrocardiogram (ECG) is performed.

The patient undergoes a brain imaging test. Depending on availability, two imaging modalities are possible: brain CT-scan without injection followed by Doppler ultrasound of the supra-aortic trunks during the week during working hours, or a CT angiography with visualization of the supra-aortic trunks at night, on weekends and on holidays. Finally, the patient benefits from close monitoring. Depending on the clinical evaluation and the examinations carried out, the neurologist based in the Emergency Department, in agreement with the emergency physician, decides on the continuation of the treatment (hospitalization / come back home, drug treatment).

The criteria for hospitalization are generally represented by the discovery of a cardiac arrhythmia, an abnormality in the brain imaging or supra-aortic trunks, repeated TIAs, a significant duration of symptoms or a history and important cardiovascular risk factors.

If the patient does not present criteria for hospitalization, a return home is offered. For 56% of patients at the CHUGA in 2019 and 62% in 2020, outpatient care was decided. These are the patients that interest us in this study. When discharging from the emergency room, the "outpatient" treatment route is relatively heavy. Treatment will eventually be initiated and the patient will have outpatient examinations as well as schedule several consultations.

The patient must in particular schedule a consultation with a cardiologist (to perform a Holter ECG and a cardiac ultrasound), carry out several additional examinations including a brain MRI and laboratory tests and schedule a follow-up with a neurologist and his attending physician. .

The aim of this study is to study the feasibility of comprehensive short-term outpatient management after hospitalization in the emergencies. We want to assess the proper performance of all the examinations prescribed from the Emergency Department, the taking of the prescribed treatment, the patient's understanding of his pathology and his feelings about his care.

Patient management is not affected by this study.

Depending on the results, we will be able to target if certain elements are not feasible and thus improve the sector or even distribute it to other centers, in particular via the RENAU.

It is a single-center prospective descriptive epidemiological study conducted at the CHUGA within the Emergency Department.

Research hypotheses and expected results The research hypothesis is that 90% of patients complete all of the 10 recommended examinations for the diagnosis of TIA, analysis of its risk factors and initiation of necessary treatments, if necessary.

This percentage is arbitrary because no such study on the subject has yet been published. This high rate seems relevant to us to reflect the proper functioning of the sector.

Being tested
Check of the different exams performed at the emergencies
Keywords
transient ischemic attack, neurovascular unit, managed care program
Medical subject headings
Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Check of the different exams performed at the emergenciesOther

    Check of the different exams performed at the emergencies

Study groups in NCT05216198
Study groupRoleWhat they receive
TIA patientsDiagnostic of TIA by the exams performed in the emergencies of CHUGA.
Receives: Other: Check of the different exams performed at the emergencies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The objective of the research is to study the feasibility of outpatient treatment for TIA from the emergency room, by evaluating the percentage of patients who have completed 100% of the additional examinations included in the course.

    The primary endpoint is the mandatory completion of the 10 items recommended by the SFNV and the RENAU, as part of the diagnosis and management of TIA:

    1. Recommended standard biology (including assessment of cardiovascular risk factors)
    2. The electrocardiogram
    3. Brain imaging
    4. Imaging of the supraortic trunks
    5. The summary of all examinations by a neurologist
    6. The introduction of antiplatelet therapy
    7. The introduction of statins
    8. The follow-up consultation with the attending physician in the month following discharge from the emergency room.
    9. Consultation with a cardiologist, with performance of an echocardiography and a Holter ECG
    10. Performing a brain MRI

    Measured: 6 months

Secondary outcomes (4)
  1. Identify the additional examinations that are not performed during the patient's care, and the difficulties in carrying out the standardized care offered to the Emergency Department

    Collection of examinations not performed during patient care

    Measured: 6 months

  2. Evaluate the patient's adherence and understanding to the care sector

    Assessment of the patient's adherence to and understanding of the sector, based on a score on 8 questions rated from 0 to 5 Use of the score in questions V of the questionnaire to assess the patient's feelings

    Measured: 6 months

  3. Identify the barriers to membership in the care sector

    Collection and interpretation of examinations not performed during patient care

    Measured: 6 months

  4. Identify complications at one month including a recurrence of TIA or stroke

    Occurrence of a complication at one month (TIA or stroke) on the declarative basis, by the patient, during the telephone call one month after discharge from the Emergency Department

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start7 Apr 2022
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

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
51 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216198
Sponsor's protocol ID
EssaiClinique_AIT-AMBU-GRE
Acronym
AIT-AMBU-GRE
Status last verified
Jan 2022
First submitted
11 Jan 2022
Last updated
24 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Amarenco P, Benavente O. EXPRESS transient ischemic attack study: speed the process! Stroke. 2008 Aug;39(8):2400-1. doi: 10.1161/STROKEAHA.108.514166. Epub 2008 Jul 3. No abstract available.

    PubMed 18599804
  • Amarenco P. Not all patients should be admitted to the hospital for observation after a transient ischemic attack. Stroke. 2012 May;43(5):1448-9. doi: 10.1161/STROKEAHA.111.636753. No abstract available.

    PubMed 22529312
  • Amarenco P, Lavallee PC, Monteiro Tavares L, Labreuche J, Albers GW, Abboud H, Anticoli S, Audebert H, Bornstein NM, Caplan LR, Correia M, Donnan GA, Ferro JM, Gongora-Rivera F, Heide W, Hennerici MG, Kelly PJ, Kral M, Lin HF, Molina C, Park JM, Purroy F, Rothwell PM, Segura T, Skoloudik D, Steg PG, Touboul PJ, Uchiyama S, Vicaut E, Wang Y, Wong LKS; TIAregistry.org Investigators. Five-Year Risk of Stroke after TIA or Minor Ischemic Stroke. N Engl J Med. 2018 Jun 7;378(23):2182-2190. doi: 10.1056/NEJMoa1802712. Epub 2018 May 16.

    PubMed 29766771
  • Lavallee PC, Meseguer E, Abboud H, Cabrejo L, Olivot JM, Simon O, Mazighi M, Nifle C, Niclot P, Lapergue B, Klein IF, Brochet E, Steg PG, Leseche G, Labreuche J, Touboul PJ, Amarenco P. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurol. 2007 Nov;6(11):953-60. doi: 10.1016/S1474-4422(07)70248-X.

    PubMed 17928270
  • Cucchiara BL, Kasner SE. All patients should be admitted to the hospital after a transient ischemic attack. Stroke. 2012 May;43(5):1446-7. doi: 10.1161/STROKEAHA.111.636746. No abstract available.

    PubMed 22529311

Questions about this trial

What is this clinical trial studying?

An observational study of Transient Ischemic Attack, run by University Hospital, Grenoble 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 8 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 24 May 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The objective of the research is to study the feasibility of outpatient treatment for TIA from the emergency room, by evaluating the percentage of patients who have completed 100% of the additional examinations included in the course. (time frame: 6 months). 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 NCT05216198, which also lists 5 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 24 May 2022.

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