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ACTIVE NOT RECRUITING
NCT05458908
NA

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

Official title: ProSPective Evaluation of the dIagnostic Accuracy of siNe spiN Noncontrast Flat-dEtectoR CT (FDCT) for the Detection of Intracranial Hemorrhage in Stroke Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2022-10-25

Completion Date

2026-03-15

Last Updated

2026-03-03

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Non-contrast cranial MDCT head scan

Non-contrast cranial MDCT imaging for visualization of the brain parenchyma (the choice of the device is up to the investigator)

DIAGNOSTIC_TEST

Non-contrast syngo DynaCT Sine Spin head scan and application software

Non-contrast syngo DynaCT Sine Spin imaging for visualization of the brain parenchyma with ARTIS icono biplane angiography system and syngo application software with syngo DynaCT Sine Spin 3-D head imaging protocol.

Locations (14)

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