Skip to main content
Clinical Trials/NCT03605355
NCT03605355UnknownNot Applicable

Feasibility Study on the Medical and Economic Consequences of an Ambulatory Transient Ischemic Attack and Minor Stroke Management

University Hospital, Toulouse1 site in 1 country200 target enrollmentStarted: September 7, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
200
Locations
1
Primary Endpoint
The average cost-effectiveness ratio at 3 month

Study Overview

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.

Detailed Description

Only two hospitals in France can take care patients with TIA or MS in an outpatient setting :Bichat hospital in Paris and Toulouse University Hospital. The effectiveness of this management has been demonstrated since recurrence stroke risk is reduced by 80% at one year. An English study (EXPRESS study) [2] showed a gain of 624 pounds with an ambulatory management compared to a conventional one. No studies are available in France on this subject.

The aim of this study is to test the feasibility of a collection of medical and economic data on a prospective way. The investigators collect medical (Cerebrovascular events, Stroke) and economic (direct and indirect costs) data concerning patients who were managed in TIA clinic in Toulouse Hospital. The medical data will be compiled with available French and International literature. The economic data will be compiled with available data in PMSI and health insurance database. This study aims to prepare a multicenter cohort to compare the cost effectiveness ratio between ambulatory and conventional management.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The average cost-effectiveness ratio at 3 month

Time Frame: 3 months

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.

Secondary Outcomes

  • Percentage of full cost collection(1 year)
  • Average cost-effectiveness ratio at one year(one 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)
  • Percentage of patients treated in TIA clinic who had first medical contact with a senior(1 day)
  • Recurrence rate of cerebro and cardiovascular events at one year(one year)
  • Percentage of patients with statin prescription at discharge(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Feasibility Study on the Medical and... | Clinical Trial