Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
362

Summary

Conditions
Stroke Ischemic
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

RATIONALE Endovascular thrombectomy (EVT) is standard treatment for acute ischemic stroke (AIS) if there is a large vessel occlusion in the anterior circulation (LVO-a). Because of its complexity, EVT is performed in selected hospitals only. Currently, approximately half of EVT eligible patients are...

RATIONALE Endovascular thrombectomy (EVT) is standard treatment for acute ischemic stroke (AIS) if there is a large vessel occlusion in the anterior circulation (LVO-a). Because of its complexity, EVT is performed in selected hospitals only. Currently, approximately half of EVT eligible patients are initially admitted to hospitals that do not provide this therapy. This delays initiation of treatment by approximately an hour, which decreases the chance of a good clinical outcome. Direct presentation of all patients with a suspected AIS in EVT capable hospitals is not feasible, since only approximately 7% of these patients are eligible for EVT. Therefore, an advanced triage method that reliably identifies patients with an LVO-a in the ambulance is necessary. Electroencephalography (EEG) may be suitable for this purpose, as preliminary studies suggest that slow EEG activity in the delta frequency range correlates with lesion location on cerebral imaging. Use of dry electrode EEG caps will enable relatively unexperienced paramedics to perform a reliable measurement without the EEG preparation time associated with 'wet' EEGs. Combined with algorithms for automated signal analysis, we expect the time of EEG recording and analysis to eventually be below five minutes, which would make stroke triage in the ambulance by EEG logistically feasible. HYPOTHESIS We hypothesize that dry electrode cap EEG can be used in patients with a suspected AIS to identify patients with an LVO-a in the ambulance. OBJECTIVE To develop and validate an algorithm based on dry electrode cap EEG data that accurately determines the likelihood of an LVO-a in patients with a suspected AIS in the ambulance. STUDY DESIGN This diagnostic study consists of four phases: Phase 1: Optimization of measurement time and software settings of the dry electrode cap EEG in a non-emergency setting in patients in whom a regular EEG is/will be performed for standard medical care. Phase 2: Optimization of measurement time and software settings of the dry electrode cap EEG in patients close to our target population in a non-emergency setting. Phase 3: Validation of several existing algorithms and development of one or more new algorithms for LVO-a detection, as well as optimization of logistics and software settings of the dry electrode EEG cap in patients close to our target population in an in-hospital emergency setting. Phase 4: Validation of several existing algorithms and algorithms developed in phase 3 for LVO-a detectionin patients with a suspected AIS in the ambulance, as well as assessment of technical and logistical feasibility of performing EEG with dry electrode caps in patients with a suspected AIS in the ambulance. STUDY POPULATION Phase 1: Patients in the outpatient clinic of the Clinical Neurophysiology department of the AMC, in whom a regular EEG has been/will be performed for standard medical care. Phase 2: Patients with an AIS admitted to the Neurology ward of the coordinating hospital with an LVO-a (after reperfusion therapy). Phase 3: Patients with a suspected AIS in the emergency room (ER) of the coordinating hospital (before reperfusion therapy). Phase 4: Patients with a suspected AIS in the ambulance. INTERVENTION Performing a dry electrode cap EEG (in phase 1 in the outpatient clinic, in phase 2 during hospital admission, in phase 3 in the ER and in phase 4 in the ambulance). MAIN END POINTS Primary end point: specificity of dry electrode cap EEG for diagnosis of LVO-a in suspected AIS patients in the ambulance; Secondary end points: Developing one or more new EEG data based algorithms, with optimal diagnostic accuracy for LVO-a detection with ambulant EEG; Sensitivity, positive predictive value (PPV) and negative predictive value (NPV) of dry electrode cap EEG for diagnosis of LVO-a in suspected AIS patients in the ambulance; Technical and logistical feasibility of performing dry electrode cap EEGs on patients with a suspected AIS in the ambulance.

Tracking Information

NCT #
NCT03699397
Collaborators
Not Provided
Investigators
Principal Investigator: Jonathan M Coutinho, MD, PhD Amsterdam UMC, University of Amsterdam