Clinical trial NCT02596607: Study of the Performance of Stroke Management in the Rhône Area
Official title: Study of the Performance of Acute Stroke Management in the Rhône Area After Implementation of a Multi-action Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: ischemic stroke, acute phase, thrombolysis, management times
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 3454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients treated for a stroke suspicion at the acute phase

Brief summary: Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. However, only a small percentage of patients access to thrombolysis on time. Various actions have been implemented since 2006 in the Rhone area as part of research projects and of the 2010-2014 national stroke action plan: training of health professionals involved in the stroke management, increase of public awareness through sensibilization campaigns, implementation of telemedicine and increase of the number of hospital beds dedicated to stroke (stroke units beds).

The main objective of the STROKE 69 study is to assess the impact of these actions on intra-hospital acute stroke management times in the Rhône area. The secondary objectives are to assess the impact of these actions on the rate and place of thrombolysis, the rate of post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3 and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and management channels.

The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016 and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and 06/06/2007, before the implementation of the actions in the Rhône area.

The cohort will be constituted of all consecutive patients treated for a stroke suspicion by the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours.

After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or transient ischemic attack (TIA) will be followed for 12 months after their inclusion by telephone calls at 3 and 12 months to assess the level of disability and mortality.

AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed strokes or TIAs.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients treated for a stroke suspicion at the acute phase ,
* with symptom onset (the last time the patient was seen without deficit ) less than 24 hours,
* Managed by the SAMU centre 15, in one of the emergency unit or stroke unit of the Rhône area
* Regardless of their geographical origin

Exclusion Criteria:

* Age under 18 years
* Symptom onset exceeding 24 hours
* Stroke during hospitalization

Primary outcomes:
measure: Intra -hospital management times
timeFrame: 24h
Secondary outcomes:
measure: Assessment of the overall impact of actions on patients management
timeFrame: 24h
measure: Assessment of the impact of public campaigns
timeFrame: 24h
measure: Assessment of the impact of the increase of stroke unit beds
timeFrame: 48h
measure: Assessment of the impact of training of SAMU centre 15 professionals and firefighters on stroke detection
timeFrame: 24h
measure: Assessment of the impact of the implementation of telemedicine
timeFrame: 24h
measure: Assessment of the impact of the actions on the prognosis of patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Department of stroke unit - Hospices Civils de Lyon
city: Bron
country: France
facility: Hôpital Desgenettes
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hôpital St Joseph St Luc
city: Lyon
country: France
facility: Urgences et Réanimation Médicale et SAMU, Hôpital Edouard Herriot
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Villefranche-sur-Saône
country: France
facility: CH Villefranche
Study officials:
affiliation: Hospices Civils de Lyon
name: Laurent DEREX, MD
role: PRINCIPAL_INVESTIGATOR
References: