Evaluating Use of Microwave Technology to Differentiate Hemorrhagic Stroke From Infarction in the Acute Phase

An Open Multicentre Trial on Suspected Stroke Patients Evaluating the Possibility to Use Microwave Technology to Differentiate Hemorrhage From Infarction in the Acute Phase

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. Follow-up microwave measurements will be performed after the acute phase. The study assesses the diagnostic capability and safety of Strokefinder MD100.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Strokefinder MD100 measurement

Detailed Description

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. Follow-up microwave measurements will be performed after the acute phase.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikael Elam, PhD, MD; Phone Number: +46(0)70-940 10 42; Email: mikael.elam@neuro.gu.se
• Study Contact Backup: Name: Stefan J Candefjord, PhD; Phone Number: +46(0)73-382 15 37; Email: stefan.candefjord@chalmers.se

Study Locations

• Sweden
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden, 413 45
      • Recruiting
      • Sahlgrenska University Hospital, Stroke Unit
      • Contact: Mikael Elam, PhD, MD; Phone Number: 070-940 10 42; Email: mikael.elam@neuro.gu.se
      • Principal Investigator: Mikael Elam, PhD, MD
      • Sub-Investigator: Jan-Erik Karlsson, PhD, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patient should be ≥ 18 years of age
• Patient has clinical signs of stroke
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemorrhagic stroke; Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. Interventions: Strokefinder MD100 measurement	Device: Strokefinder MD100 measurement; A microwave measurement will be performed with the patient lying in the hospital bed or another suitable surface. Follow-up microwave measurements will be performed after the acute phase.
Experimental: Ischemic stroke; Patient group B is defined as patients that are diagnosed with ischemic stroke. Interventions: Strokefinder MD100 measurement	Device: Strokefinder MD100 measurement; A microwave measurement will be performed with the patient lying in the hospital bed or another suitable surface. Follow-up microwave measurements will be performed after the acute phase.
Experimental: Stroke mimics; Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke. Interventions: Strokefinder MD100 measurement	Device: Strokefinder MD100 measurement; A microwave measurement will be performed with the patient lying in the hospital bed or another suitable surface. Follow-up microwave measurements will be performed after the acute phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for patient group A vs. group B, using the leave-one-out cross validation (LOOCV) method	The diagnostic procedure will take less than 5 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B, using the LOOCV method	The diagnostic procedure will take less than 5 minutes
Any adverse events occurring within 24 hours from the measurement procedure(s)	Within 24 hours

Collaborators and Investigators

• Sponsor: Mikael Elam
• Collaborators: Chalmers University of Technology; Medfield Diagnostics
• Investigators: Principal Investigator: Mikael Elam, PhD, MD, Sahlgrenska University Hospital, Department of Clinical Neurophysiology

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke
• Other Study ID Numbers: VGR 01