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

Completed · Not applicable

Conditions studied: Stroke

In brief

Stroke is one of the leading causes of mortality and disability worldwide. Optimization of intra-hospital pathways is as of today one of the most promising research topics in stroke treatment. A potential solution to shorten the time needed for current workflows, and therefore reperfusion, is to do both imaging and subsequent endovascular therapy (EVT) in the angiography suite using non-contrast syngo DynaCT Sine Spin (FDCT) for the exclusion of intracranial hemorrhage and flat detector CT angiography (FDCTA) or digital subtraction angiography for diagnosis of LVO. It is still a matter of debate if FDCT can reliably differentiate between ischemic and hemorrhagic stroke. This study aims to investigate if non-contrast syngo DynaCT Sine Spin imaging is non-inferior to non-contrast MDCT imaging regarding its sensitivity and specificity for the detection of intracranial hemorrhages.

Key facts

Study ID

NCT05458908

Run by

University Hospital, Basel, Switzerland

People needed

252

Starts

2022-10-25

Expected to finish

2026-02-28

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Swedish Medical Center — Denver, Colorado, United States
• AdvocateAurora Health — Chicago, Illinois, United States
• Nortshore University Health System — Chicago, Illinois, United States
• New York University Langone Health — New York, New York, United States
• Mount Sinai Health System — New York, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Semmes Murphy Clinic — Memphis, Tennessee, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• HUS — Helsinki, Finland
• CHRU de Tours — Tours, France
• Hospital Vall d'Hebron — Barcelona, Spain
• University Hospital Basel — Basel, Switzerland
• Inselspital Bern — Bern, Switzerland
• Kantonsspital Luzern — Lucerne, Switzerland

Full record on ClinicalTrials.gov

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