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Study of the Performance of Stroke Management in the Rhône Area

NCT02596607 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3454

Last updated 2018-02-07

No results posted yet for this study

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Laurent DEREX, MD · Hospices Civils de Lyon

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-06
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02596607 on ClinicalTrials.gov