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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03181412
Other study ID # 69HCL17_0146
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 25, 2018
Est. completion date January 31, 2022

Study information

Verified date November 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1272
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Consecutive patients calling emergency medical services for suspected acute ischemic stroke Exclusion Criteria: - Symptom onset (or the last time the patient was seen without deficit ) of more than 6 hours

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Questionnaire
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.

Locations

Country Name City State
France Neurologie, Hôpital Neurologique - HCL Bron
France Médecine d'urgence, Clinique de la Sauvegarde Lyon
France Médecine d'urgence, Hôpital de la Croix-Rousse - HCL Lyon
France Médecine d'urgence, Hôpital Desgenettes Lyon
France Médecine d'urgence, Hôpital Mutualiste Médipôle Lyon
France Médecine d'urgence, Hôpital Saint Joseph Saint Luc Lyon
France SAMU 69 , Hôpital Edouard Herriot Lyon
France Urgentiste, Centre Hospitalier Lyon Sud Pierre-Bénite
France Médecine d'urgence, CH de Roanne Roanne
France Médecine d'urgence, Hôpital Nord-Ouest Tarare
France Services Médecine d'urgence et Neurologie, CH de Vienne Vienne
France Services Neurologie et Médecine d'urgence, CH de Villefranche sur Saône Villefranche-sur-Saône

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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