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

Description

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.

Conditions

Stroke

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Denver

Swedish Medical Center, Denver, Colorado, United States, 80210

Chicago

Nortshore University Health System, Chicago, Illinois, United States, 60201

Memphis

Semmes Murphy Clinic, Memphis, Tennessee, United States, 38120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University Hospital, Basel, Switzerland,

Marios-Nikos Psychogios, Prof Dr, PRINCIPAL_INVESTIGATOR, University Hospital, Basel, Switzerland

Adam S Arthur, MD, MPH, STUDY_CHAIR, Semmes Murphey Clinic and University of Tennessee Health Sciences Center

Study Record Dates

2025-07-01