Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes
MEDECO-AIT
2 other identifiers
observational
200
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedStudy Start
First participant enrolled
September 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 31, 2019
January 1, 2019
1.2 years
July 19, 2018
January 29, 2019
Conditions
Keywords
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hélène Derumeaux-Burel, MD
University Hospital, Toulouse
Central Study Contacts
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