Study of the Performance of Stroke Management in the Rhône Area

NCT ID: NCT02596607

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3454 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-06

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurent DEREX, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of stroke unit - Hospices Civils de Lyon

Bron, , France

Site Status

Hôpital Desgenettes

Bron, , France

Site Status

Hôpital de la Croix Rousse

Lyon, , France

Site Status

Hôpital St Joseph St Luc

Lyon, , France

Site Status

Urgences et Réanimation Médicale et SAMU, Hôpital Edouard Herriot

Lyon, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

CH Villefranche

Villefranche-sur-Saône, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

69HCL15_0076

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurothrombectomy France
NCT02880579 COMPLETED
Minor Stroke Therapy Evaluation
NCT03796468 RECRUITING NA
Giessen Stroke Registry
NCT05295862 RECRUITING
Post-Stroke Medication Relay
NCT04697979 UNKNOWN