Overview

This trial is active, not recruiting.

Condition stroke
Treatments strokefinder md100 prehospital measurement, strokefinder md100 hospital measurement
Sponsor Mikael Elam
Collaborator Medfield Diagnostics
Start date July 2015
End date April 2017
Trial size 500 participants
Trial identifier NCT02490306, VGR 01

Summary

This is a prospective, open, multicenter study that will enroll patients with clinical signs of stroke in the prehospital setting. A follow-up microwave measurement will be performed by the hospital investigator for the patients admitted to the Stroke Unit at Sahlgrenska University Hospital in conjunction with a CT scan, if this is performed as part of the standard of care within 48 hours of stroke onset. The study assesses the diagnostic capability, measurement performance, safety and usability of Strokefinder MD100 in a prehospital environment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. Note that the diagnosis is not known in the prehospital phase of the study. Interventions: Strokefinder MD100 prehospital measurement; Strokefinder MD100 hospital measurement
strokefinder md100 prehospital measurement
A prehospital microwave measurement will be performed with the patient lying on the ambulance stretcher or another suitable surface.
strokefinder md100 hospital measurement
A follow-up microwave measurement will be performed at the hospital in conjunction with a Computed Tomography (CT) scan, if this is performed as part of the standard of care within 48 hours of stroke onset.
(Experimental)
Patient group B is defined as patients that are diagnosed with ischemic stroke. Note that the diagnosis is not known in the prehospital phase of the study. Interventions: Strokefinder MD100 prehospital measurement; Strokefinder MD100 hospital measurement
strokefinder md100 prehospital measurement
A prehospital microwave measurement will be performed with the patient lying on the ambulance stretcher or another suitable surface.
strokefinder md100 hospital measurement
A follow-up microwave measurement will be performed at the hospital in conjunction with a Computed Tomography (CT) scan, if this is performed as part of the standard of care within 48 hours of stroke onset.
(Experimental)
Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke. Note that the diagnosis is not known in the prehospital phase of the study. Interventions: Strokefinder MD100 prehospital measurement
strokefinder md100 prehospital measurement
A prehospital microwave measurement will be performed with the patient lying on the ambulance stretcher or another suitable surface.

Primary Outcomes

Measure
The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for patient groups A and B in the prehospital setting, using the leave-one-out cross validation (LOOCV) method
time frame: The diagnostic procedure will take less than 5 minutes

Secondary Outcomes

Measure
The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B in the prehospital setting, using the LOOCV method
time frame: The diagnostic procedure will take less than 5 minutes
The diagnostic ability as measured by the AUC of the device for patient groups A and B in the hospital setting, using the LOOCV method
time frame: The diagnostic procedure will take less than 5 minutes
The proportion of patients that the device will deliver adequate measurement data for in the prehospital setting
time frame: The diagnostic procedure will take less than 5 minutes
Mean time (± standard deviation) needed from arrival at patient side to completion of measurement procedure in the prehospital setting
time frame: The diagnostic procedure will take less than 5 minutes
Mean time (± standard deviation) needed to complete the measurement procedure (prehospital and hospital settings)
time frame: The diagnostic procedure will take less than 5 minutes
Any adverse events occurring within 24 hours from the measurement procedure(s)
time frame: Within 24 hours

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient should be ≥ 18 years of age - Patient has clinical signs of stroke - Patient/close relative confirms orally that the patient wants to participate in the study (during acute phase) - Signed Informed Consent Form (after acute phase) Exclusion Criteria: - Pregnant or nursing woman - Woman of child bearing potential and not taking adequate contraceptive precautions - 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

Additional Information

Official title An Open Multicenter Study on Suspected Stroke Patients Evaluating the Possibility to Use Microwave Technology to Differentiate Hemorrhage From Infarction Before Arrival to Hospital
Principal investigator Mikael Elam, PhD, MD
Description This is a prospective, open, multicenter study that will enroll patients with clinical signs of stroke in the prehospital setting. When the dispatch center (in Sweden SOS Alarm 112) decides to dispatch an ambulance with highest priority (1, with lights/sirens active) for a suspected case of stroke, a research nurse staffed single responder vehicle equipped with Strokefinder MD100 will be dispatched to the scene, if deemed possible to reach the site ahead of the first ambulance. The research nurse will evaluate if the patient fulfills all of the inclusion criteria and none of the exclusion criteria, on delegation from the prehospital investigator. If confirmed to be suitable for the study the patient is asked about verbal informed consent. If the answer is affirmative the microwave measurement will be performed with the patient lying on the ambulance stretcher or another suitable surface. The procedure will take less than five minutes (the duration of the actual measurement is < 1 minute) and will not interfere with the patient's standard of care during transport or at the receiving hospital. Written informed consent is acquired by the hospital investigator, as soon as possible after the acute phase of care is completed. A follow-up microwave measurement will be performed by the hospital investigator for the patients admitted to the Stroke Unit at Sahlgrenska University Hospital/Sahlgrenska in conjunction with a Computed Tomography (CT) scan, if this is performed as part of the standard of care within 48 hours of stroke onset. 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. The time from arrival at patient side to completion of measurement procedure, and the duration for the measurement procedure itself, will be measured. Safety will be evaluated throughout the study, and a safety follow-up will be performed by the hospital investigator 24 hours after the last microwave measurement is finalized. No further follow-up of patients is planned.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Sahlgrenska University Hospital, Sweden.