Mobile Microwave-based Diagnosis and Monitoring of Stroke

Study Overview
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Brief Summary
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This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The study assesses the diagnostic capability and safety of Strokefinder MD100.

Detailed Description
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This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The investigator will assess and control the inclusion/exclusion criteria. If the patient is confirmed to be suitable for the trial, the patient is asked to give oral informed consent. If the answer is affirmative the microwave measurement will be performed. The procedure will take less than five minutes (the duration of the actual measurement procedure is 1.5 minutes) and will not interfere with the patient's standard of care during the hospital stay. Written informed consent is acquired by the investigator, as soon as possible after the acute phase of care is completed. The measurement data will be evaluated for the presence of signal artifacts. The diagnostic ability of the device will be evaluated using a leave-one-out cross validation (LOOCV) method with the CT diagnosis as ground truth. Safety will be evaluated throughout the trial, and a safety follow-up will be performed by the investigator 24 hours after the last microwave measurement. No further follow-up of patients is planned.

Official Title
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Mobile Microwave-based Diagnosis and Monitoring of Stroke: on the Road Towards Improved Stroke Triage and Care, Including Prehospital Initiation of Thrombolytic Treatment

Conditions
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Stroke, Acute, Intracerebral Hemorrhage

Intervention / Treatment
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* Diagnostic Test: Hemorrhagic stroke group (group A)
* Diagnostic Test: Ischemic stroke group (group B)
* Diagnostic Test: Stroke mimic group (group C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with clinical signs of stroke Patient should be ≥ 18 years of age Patient/next of kin confirms orally that the patient wants to participate in the trial (during acute phase) Signed Informed Consent Form (after acute phase) Exclusion Criteria: Pregnant or nursing woman Fertile woman where pregnancy cannot be excluded Patient diagnosed with a condition associated with risk of poor protocol compliance The diagnostic procedure is deemed to interfere with the standard of care Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrolment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemorrhagic stroke group (group A)<br>Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. | Diagnostic Test: Hemorrhagic stroke group (group A)<br>* Group A: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.<br>|
| Experimental: Ischemic stroke group (group B)<br>Patient group B is defined as patients that are diagnosed with ischemic stroke. | Diagnostic Test: Ischemic stroke group (group B)<br>* Group B: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.<br>|
| Experimental: Stroke mimic group (group C)<br>Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke. | Diagnostic Test: Stroke mimic group (group C)<br>* Group C: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the diagnostic ability of the device to diagnose hemorrhagic stroke and ischemic stroke in the prehospital and hospital setting | The diagnostic ability as measured by the area under the curve of the device for patient groups (group C vs. groups A + B) using the LOOCV method | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events within 24 hours | Any adverse events occurring within 24 hours from the measurement procedure(s) | Baseline to 24 hours | 
| To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics | To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics from patients with stroke (hemorrhagic stroke and ischemic stroke) in the prehospital and hospital setting | Baseline | 
| To evaluate the delivery of adequate measurement data from the device | To evaluate the delivery of adequate measurement data from the device in the prehospital and hospital setting | Baseline | 
| To evaluate the amount of time needed to perform the measurement procedures | To evaluate the amount of time needed to perform the measurement procedures in the prehospital and hospital settings | Basline |