Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes

NCT ID: NCT03605355

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-07
• Study Completion Date: 2020-12-31

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.

Conditions

Transient Ischemic Attack

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hélène Derumeaux-Burel, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Countries

France

Central Contacts

Hélène Derumeaux-Burel, MD

Role: CONTACT

derumeaux.h@chu-toulouse.fr

05 61 77 87 75

Isabelle Olivier, PhD

Role: CONTACT

olivier.i@chu-toulouse.fr

05 61 77 70 51 ext. 33

Facility Contacts

Hélène Derumeaux-Burel, MD

Role: primary

derumeaux.h@chu-toulouse.fr

05 61 77 87 75 ext. 33

Isabelle Olivier, PhD

Role: backup

olivier.i@chu-toulouse.fr

05 61 77 70 51

Other Identifiers

2018-A01444-51

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17/0349

Identifier Type: -

Identifier Source: org_study_id