Study of the Performance of Stroke Management in the Rhône Area

NCT02596607 | Completed

• 1 other identifier: 69HCL15_0076
• Study Type: observational
• Target: 3,454
• Locations: 1 country
• Sites: 7

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.

Conditions

Stroke

Keywords

ischemic stroke, acute phase, thrombolysis, management times

Outcome Measures

Primary Outcomes (1)

• Intra -hospital management times

  * Admission - brain imaging time * Admission- arrival at stroke unit time * Brain imaging time - arrival at stroke unit time * Admission period - thrombolysis time (door-to-needle time)

  24h

Secondary Outcomes (6)

• Assessment of the overall impact of actions on patients management

  24h

• Assessment of the impact of public campaigns

  24h

• Assessment of the impact of the increase of stroke unit beds

  48h

• Assessment of the impact of training of SAMU centre 15 professionals and firefighters on stroke detection

  24h

• Assessment of the impact of the implementation of telemedicine

  24h

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients treated for a stroke suspicion at the acute phase

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (7)

Department of stroke unit - Hospices Civils de Lyon

Bron, 69500, France

Location

Hôpital Desgenettes

Bron, France

Location

Hôpital de la Croix Rousse

Lyon, France

Location

Hôpital St Joseph St Luc

Lyon, France

Location

Urgences et Réanimation Médicale et SAMU, Hôpital Edouard Herriot

Lyon, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

CH Villefranche

Villefranche-sur-Saône, France

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Laurent DEREX, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 4, 2015
• Study Start: November 6, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

FR (7)