NCT03605355

Brief Summary

The effectiveness of outpatient management of minor TIAs and strokes in the context of a dedicated outpatient pathway with specialized care has been demonstrated and has resulted in an 80% decrease in stroke in the year followed the AIT (EXPRESS and SOS-TIA studies) At the same time, few studies have been conducted on their economic interest and none in France. Patient's typology (younger patient, no sequel, no disability) with Transient ischemic attack (TIA) and minor stroke (MS) makes them compatible with ambulatory management.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 19, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 7, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

July 19, 2018

Last Update Submit

January 29, 2019

Conditions

Keywords

minor strokecost-effectivenessfeasibilityday clinic

Outcome Measures

Primary Outcomes (1)

  • The average cost-effectiveness ratio at 3 month

    The average cost-effectiveness ratio at 3 month where the effectiveness is the 3-month cerebro vascular event rate and the costs taken into account are medical and non-medical direct costs and indirect costs limited to work stoppages.

    3 months

Secondary Outcomes (8)

  • Percentage of full cost collection

    1 year

  • Concordance between monitoring data collected in different database

    1 year

  • Recurrence rate of cerebro and cardiovascular events at 7 days

    7 days

  • Recurrence rate of cerebro and cardiovascular events at 3 months

    3 months

  • Recurrence rate of cerebro and cardiovascular events at one year

    one year

  • +3 more secondary outcomes

Eligibility Criteria

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

Stroke patients, to adapt to the recent change in the typology of new ischemic stroke in Western Europe, which for the most part are transient (30%) or minor ischemic strokes (35%). %). The profile of these patients is indeed compatible with outpatient care which should lead to the adaptation of the offer of care.

You may qualify if:

  • Hospitalization in the TIA clinic in Toulouse Hospital (a day clinic)
  • Having presented within the previous 7 days a transient ischemic attack or a minor stroke
  • Affiliated to a social protection system
  • To have given no opposition to participation in the study

You may not qualify if:

  • Patients with a transient ischemic attack - mimic (such as migraine or seizure)
  • Patients under protection of justice
  • Pregnant and / or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hélène Derumeaux-Burel, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène Derumeaux-Burel, MD

CONTACT

Isabelle Olivier, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 19, 2018

First Posted

July 30, 2018

Study Start

September 7, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations