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

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT05458908
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-14
• Study Start: 2022-10-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-04-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Occurrence of an intracranial hemorrhage (yes/no)	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.

Trial Locations

Locations (14)

AdvocateAurora Health; 🇺🇸 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

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

CHRU de Tours; 🇫🇷 Tours, France

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Swedish Medical Center; 🇺🇸 Denver, Colorado, United States

Nortshore University Health System; 🇺🇸 Chicago, Illinois, United States

Semmes Murphy Clinic; 🇺🇸 Memphis, Tennessee, United States

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