ProSPective Evaluation of Non-contrast sINe spiN Flat-dEtectoR CT for the Detection of Intracranial hemorrhageS

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jul 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called non-contrast syngo DynaCT Sine Spin to see if it can effectively detect bleeding in the brain (intracranial hemorrhages) in patients who have had a stroke. The goal is to find out if this new method is just as good as the standard imaging method currently used, which is non-contrast MDCT. The trial is important because being able to quickly and accurately identify the type of stroke can help doctors provide faster treatment to patients, which can improve outcomes.

To participate in this study, you must be at least 18 years old and have symptoms that suggest you may have had a stroke. This includes a specific score on a stroke severity scale and a recent brain scan showing potential stroke signs. Additionally, you need to be able to give informed consent, either by signing a form or through emergency procedures. If you join the trial, you can expect to undergo the new imaging method within a few hours of your symptoms appearing, and your doctor will guide you through the process. It's also important to note that certain factors, like severe metal artifacts in previous scans or planned surgeries, may prevent you from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed Consent as documented by signature or fulfilling the criteria for emergency or deferral consent
• • Patients with symptoms suggestive of ischemic stroke (NIHSS ≥ 7) or suggestive of haemorrhagic stroke with a cranial non-contrast MDCT and a feasible non-contrast syngo DynaCT Sine Spin within 4 hours
• • Patient presenting within 24 hours of last seen well
• • Patients presenting directly to the treating hospital (i.e. mothership patients) OR transfer patients with the indication for repeated imaging according to the standard operation procedures of the treating hospital
• • Age above 18 years
• • Agreement of treating physician to perform non-contrast syngo DynaCT Sine Spin
• Exclusion Criteria:
• • Severe metal artifacts on initial MDCT imaging
• • Planned invasive interventions between MDCT and FDCT scan
• • Clinical deterioration between MDCT and FDCT scan (i.e. an increase of the NIHSS of more than 4 points)
• • Evidence of an ongoing pregnancy prior to enrollment. A negative pregnancy test before enrollment is required for all women with child-bearing potential