Visio-conference for Pre-hospital Triage of Stroke Suspicions (OPTIC-AVC)

Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device

Interventionnal Study to investigate the accuracy of our clinical based algorithm performed by using a visioconference device to assess the eligibility of acute recanalisation treatment (intraveinous thrombolysis (IVT) and/or mechanical thrombectomie (TM). Clinical identification of type of treatment is needed is pre-hospital triage of these patients.

Study Overview

• Status: Completed
• Conditions: Stroke; Cerebrovascular Disorders; Stroke, Ischemic; Stroke, Acute
• Intervention / Treatment: Procedure: Visio conference device evaluation (DVCM)

Detailed Description

The outcome of ischemic stroke (IS) with large artery occlusion (LVO) is related to the volume of infarcted brain witch is related to the delay of arterial recanalisation. IVT is available in multiple stroke units in France but, in case of LVO, the association with TM is needed. The availability of endovascular capable centers is limited to tertiary care hospitals. As a result, pre-hospital identification of these patients is a priority and the optimization of the triage can be done by a clinical algorithm carried out by a neurological tele-evaluation.

OPTIC-AVC is a multi-phase study. This phase is about the evaluation of accuracy of our algorithm performed by a quick and standardized neurological tele-evaluation to predict the eligibility for recanalisation treatment (IVT and/or TM) of patients suspected of acute stroke in the emergency setting. The effective therapeutic decision for each patient, performed by another neurologist, will be blind to the theoretical therapeutic decision resulting from the algorithm.

Theoretical and effective therapeutic decision will be compared a posteriori

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33 076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age over 18
• Suspicion of acute symptomatic stroke whose first symptoms are less than 24 hours old
• Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)

Exclusion Criteria:

• Stupor or coma requiring orotracheal intubation
• Rankin pre stroke > 4
• Severe cognitive impairement
• Contraindication to the realiszation of angiographic imaging
• Participation refusal
• Patient under legal protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visio conference device evaluation; Neurological tele-evaluation by a neurologist	Procedure: Visio conference device evaluation (DVCM); Standard neurological tele-evaluation (limited to 15minutes) remotely carried out by a first neurologist via a tablet (DVCM) and an operator. A second neurologist assist at the assessment without intervention next to the patient. Once the remote assessment is complet, the second neurologist ensure the continuation of standard patient care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final effective therapeutic decision	Thrombolysis and/or thrombectomy : yes/no	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic conviction	Theoretical conviction using Likert scales between the neurologist at the patient bedside and the neurologist using the device for tele-evaluation	Day 0
Remote evaluation failure	Remote evaluation failure rate	Day 0
Theoretical therapeutic decision	Theoretical therapeutic decision of the algorithm : thrombolysis and/or thrombectomy [yes/no]	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Mechanical thrombectomy; Emergency medical service; Pre hospital; Tele-evaluation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke; Cerebrovascular Disorders
• Other Study ID Numbers: CHUBX 2017/42; 2018-A03123-52 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No