Stroke Cincinnati Prehospital Stroke Severity Scale Evaluation iN prEhospital


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Verified June 2017 by Hospices Civils de Lyon

Sponsor:

Information provided by (Responsible Party):

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03181412

First received: June 7, 2017

Last updated: June 7, 2017

Last verified: June 2017

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.

Stroke Diagnostic Test: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Performances of the Cincinnati Prehospital Stroke Severity Scale Realized During Telephone Call With Emergency Department Physicians to Predict Large-vessel Occlusion

Primary Outcome Measures:

  • Performances of Cincinnati prehospital stroke severity scale [ Time Frame: 1 day ]

    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.

Estimated Enrollment: 1220
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03181412

SAMU 69 , Hôpital Edouard Herriot
Lyon, France, 69003
Contact: Thomas BONY, Dr       thomas.bony@chu-lyon.fr   

Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03181412     History of Changes
Other Study ID Numbers: 69HCL17_0146
Study First Received: June 7, 2017
Last Updated: June 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on June 08, 2017