In- and exclusion criteria.

RationaleWhether syngo DynaCT Sine Spin non-contrast flat detector CT (FDCT) imaging is sufficient to rule out intracranial hemorrhage in suspected acute stroke patients is unknown.AimTo determine if syngo DynaCT Sine Spin non-contrast FDCT imaging is non-inferior to conventional multidetector CT (MDCT) imaging for the detection and exclusion of intracranial hemorrhages in suspected acute stroke patients.Sample sizeTo enroll 252 participants in three buckets (126 ischemic stroke patients, 126 hemorrhagic stroke patients (including 14 patients with an isolated infratentorial hemorrhage).Methods and designA multicenter, international, prospective, cross-sectional, endpoint assessor blinded, non-inferiority trial.OutcomesThe primary outcome is the occurrence of an intracranial hemorrhage (yes versus no). This will be used to calculate the sensitivity and specificity of FDCT imaging for the detection of intracranial hemorrhages. All FDCT images will be rated by six independent raters in a blinded imaging core-lab. The rating of the MDCT images will be deemed as ground-truth. FDCT imaging will be deemed non-inferior if the lower bound of the 95%-Confidence Interval of the sensitivity and specificity is above 95%.DiscussionThis trial will inform physicians whether syngo DynaCT Sine Spin non-contrast FDCT imaging can reliably exclude intracranial hemorrhages in patients with suspected acute stroke.Trial registrationClinicalTrials.gov NCT05458908