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

ID#: NCT05458908

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 25, 2022

End Date: July 01, 2025

Contact Information:
Marios-Nikos Psychogios, Prof Dr
+41 61 328 59 36
Alex Brehm, PhD
+41 61 328 51 72
Summary: 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.
Eligibility:

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
Find a Clinical Trial Find Cancer Clinical Trials