NCT03181412

Brief Summary

The effectiveness of acute ischemic stroke (AIS) management has improved considerably in recent years with thrombolysis and more recently with mechanical thrombectomy (MT). Currently, mechanical thrombectomy can only be performed in stroke unit with an interventional neuroradiology center by experienced/qualified interventional neuroradiologists. In the Rhone area, only one hospital has the authorization to perform mechanical thrombectomy. Therefore, transferring directly eligible acute ischemic stroke patients for mechanical thrombectomy to this center constitutes an important stake of the triage of suspected acute ischemic stroke patients. Some validated scores for the identification of severe strokes and large vessel occlusion, including the Cincinnati prehospital stroke severity scale (CPSSS), appear to be relevant for pre-hospital use in order to identify patients potentially eligible for mechanical thrombectomy and address them to a stoke unit with interventional radiology center.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

3.6 years

First QC Date

June 7, 2017

Last Update Submit

November 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performances of Cincinnati prehospital stroke severity scale

    The Cincinnati prehospital stroke severity scale is composed of 3 items: 2 points if the patient has a deviation of the gaze, 1 point if the patient is not able to give the date and answer to a simple order such as closing the eyes or clenching the fist and 1 point if the patient presents a hemiplegia. The CPSSS score ranges from 0 to 4, highest value indicating the worst score. It will be considered positive if it is equal to 2 or more. Performances will be evaluated in terms of sensitivity, specificity, positive and negative predictive values.

    1 day

Study Arms (1)

Patients with suspected ischemic stroke

The cohort will be constituted of patients treated for a stroke suspicion after calling emergency medical services of the Rhone and presenting a symptom-onset (the last time the patient was seen without deficit) less than 6 hours.

Diagnostic Test: Questionnaire

Interventions

QuestionnaireDIAGNOSTIC_TEST

Tests from Cincinnati prehospital stroke severity scale (CPSSS) will be carried out by the physician at emergency medical services on telephone call with firemen, paramedics or the emergency medical services team for any stroke suspicion that meets the criteria for inclusion. Emergency department physician will have to follow a standardized questionnaire to complete the different items of the score. The score will not be calculated by emergency department physician and will not influence the orientation and management of patients. The final diagnosis will be the presence or absence of a large vessel occlusion. This diagnosis will be done on cerebral imaging by a neurologist.

Patients with suspected ischemic stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stroke of the Rhone area after emergency medical services call

You may qualify if:

  • Consecutive patients calling emergency medical services for suspected acute ischemic stroke

You may not qualify if:

  • Symptom onset (or the last time the patient was seen without deficit ) of more than 6 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Neurologie, Hôpital Neurologique - HCL

Bron, France

Location

SAMU 69 , Hôpital Edouard Herriot

Lyon, 69003, France

Location

Médecine d'urgence, Clinique de la Sauvegarde

Lyon, France

Location

Médecine d'urgence, Hôpital de la Croix-Rousse - HCL

Lyon, France

Location

Médecine d'urgence, Hôpital Desgenettes

Lyon, France

Location

Médecine d'urgence, Hôpital Mutualiste Médipôle

Lyon, France

Location

Médecine d'urgence, Hôpital Saint Joseph Saint Luc

Lyon, France

Location

Urgentiste, Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

Médecine d'urgence, CH de Roanne

Roanne, France

Location

Médecine d'urgence, Hôpital Nord-Ouest

Tarare, France

Location

Services Médecine d'urgence et Neurologie, CH de Vienne

Vienne, France

Location

Services Neurologie et Médecine d'urgence, CH de Villefranche sur Saône

Villefranche-sur-Saône, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 8, 2017

Study Start

June 25, 2018

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations