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Trial record 1 of 1 for:    NCT05458908
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ProSPective Evaluation of Non-contrast sINe spiN Flat-dEtectoR CT for the Detection of Intracranial hemorrhageS (SPINNERS)

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ClinicalTrials.gov Identifier: NCT05458908
Recruitment Status : Not yet recruiting
First Posted : July 14, 2022
Last Update Posted : July 22, 2022
Sponsor:
Collaborator:
Siemens Healthineers AG
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.


Condition or disease Intervention/treatment Phase
Stroke Diagnostic Test: Non-contrast cranial MDCT head scan Diagnostic Test: Non-contrast syngo DynaCT Sine Spin head scan and application software Not Applicable

Detailed Description:

Despite concerted efforts, stroke is still one of the leading causes of mortality and disability worldwide.Stroke can be divided into two main types: ischemic and hemorrhagic stroke. Endovascular therapy (EVT) became the gold-standard for the treatment of acute ischemic stroke due to large-vessel occlusions (LVO). However, as was shown by a post-hoc meta-analysis of five trials clinical outcome is highly associated with the time from hospital admission to treatment.

One possibility to substantially shorten this time span is the implementation of a One Stop Management approach. In this workflow both imaging and subsequent EVT is done in the angiography suite using non-contrast flat detector CT (FDCT) for the exclusion of an intracranial hemorrhage. Such workflows dramatically reduce intra-hospital time delays (median reductions of more than 30 minutes) and are associated with improved patient outcomes. One of the biggest hurdles for a large-scale implementation of a One Stop Management approach up to now is the ability to differentiate between ischemic and hemorrhagic stroke with FDCT. In a recent study we have reported very high sensitivity and specificity for the detection of intracranial hemorrhage with FDCT.

Recently Siemens Healthineers introduced the new ARTIS icono angiography system with a new non-contrast syngo DynaCT Sine Spin protocol FDCT, which should improve the quality and soft tissue resolution of native cranial FDCT scans especially in the posterior fossa and skull base. Therefore, the study aims to evaluate if non-contrast syngo DynaCT Sine Spin FDCT is non-inferior to non-contrast multidetector CT (MDCT) for the detection of intracranial hemorrhages.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cross-sectional non-inferiority investigation with prospective open label data collection and blinded endpoint assessment
Masking: None (Open Label)
Masking Description: Blinded assessment of outcome events through an independent Core-Lab
Primary Purpose: Diagnostic
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
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Cranial non-contrast syngo DynaCT Sine Spin scan
There is only one arm as all patients undergo the same intervention. Subjects with clinical features/symptoms of a stroke (hemorrhagic and non-hemorrhagic stroke patients) will be enrolled. All patients will undergo first a non-contrast MDCT scan and then a non-contrast syngo DynaCT Sine Spin head scan within a maximum timespan of 4 hours between both scans. Only patients in which no invasive procedure in between is planned can be enrolled.
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.




Primary Outcome Measures :
  1. Occurrence of an intracranial hemorrhage (yes/no) [ Time Frame: Day 0 - within 4 hours of enrollment ]

    The primary outcome is the occurrence of intracranial hemorrhages (yes vs no) as assessed by a blinded core-lab. The primary outcome will be used to calculate the sensitivity and specificity of non-contrast syngo DynaCT Sine Spin imaging for the detection of intracranial hemorrhages.

    The primary outcome will be assessed on both scans.



Other Outcome Measures:
  1. Change in Adverse Device Events (ADEs) [ Time Frame: At 24 h ± 6h after enrollment ]
    All device related adverse events (ADEs) will be evaluated up to 24 hours after the study intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05458908


Contacts
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Contact: Marios-Nikos Psychogios, Prof Dr +41 61 328 59 36 marios.psychogios@usb.ch
Contact: Alex Brehm, PhD +41 61 328 51 72 alex.brehm@usb.ch

Locations
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Switzerland
University Hospital Basel
Basel, Switzerland
Contact: Alex Brehm, PhD         
Principal Investigator: Marios-Nikos Psychogios, Prof Dr         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Siemens Healthineers AG
Investigators
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Principal Investigator: Marios-Nikos Psychogios, Prof Dr University Hospital, Basel, Switzerland
Study Chair: Adam S Arthur, MD, MPH Semmes Murphey Clinic and University of Tennessee Health Sciences Center
Publications:
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT05458908    
Other Study ID Numbers: qu20Psychogios_SPINNERS
First Posted: July 14, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
hemorrhagic stroke
ischemic stroke
large-vessel occlusions (LVO)
cone beam CT
intracranial hemorrhage
flat detector computer tomography (FDCT)
Additional relevant MeSH terms:
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Stroke
Intracranial Hemorrhages
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes