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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042584
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Stroke, Acute Stroke, Ischemic Cerebrovascular Disorders Procedure: Visio conference device evaluation (DVCM) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Final effective therapeutic decision [ Time Frame: Day 0 ]
    Thrombolysis and/or thrombectomy : yes/no


Secondary Outcome Measures :
  1. Therapeutic conviction [ Time Frame: Day 0 ]
    Theoretical conviction using Likert scales between the neurologist at the patient bedside and the neurologist using the device for tele-evaluation

  2. Remote evaluation failure [ Time Frame: Day 0 ]
    Remote evaluation failure rate

  3. Theoretical therapeutic decision [ Time Frame: Day 0 ]
    Theoretical therapeutic decision of the algorithm : thrombolysis and/or thrombectomy [yes/no]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042584


Contacts
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Contact: Ludovic LUCAS 05-56- 79-54- 45 ludovic.lucas@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Recruiting
Bordeaux, France, 33 076
Contact: Ludovic Lucas    05-56- 79-54- 45    ludovic.lucas@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04042584    
Other Study ID Numbers: CHUBX 2017/42
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Stroke
Mechanical thrombectomy
Tele-evaluation
Emergency medical service
Pre hospital
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases