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| Name | Class |
|---|---|
| Siemens Healthineers AG | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cranial non-contrast syngo DynaCT Sine Spin scan | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-contrast cranial MDCT head scan | Diagnostic Test | Non-contrast cranial MDCT imaging for visualization of the brain parenchyma (the choice of the device is up to the investigator) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of an intracranial hemorrhage (yes/no) | 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. | Day 0 - within 4 hours of enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Adverse Device Events (ADEs) | All device related adverse events (ADEs) will be evaluated up to 24 hours after the study intervention. | At 24 h ± 6h after enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marios-Nikos Psychogios, Prof Dr | University Hospital, Basel, Switzerland | Principal Investigator |
| Nitin Goyal, MD | Semmes Murphey Clinic and University of Tennessee Health Sciences Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Medical Center | Denver | Colorado | 80210 | United States | ||
| AdvocateAurora Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40875663 | Background | Psychogios M, Brehm A, Goyal N, Boulouis G, Burkhardt JK, Chowdhry SA, Frei D, Gralla J, Kaesmacher J, Kellogg RT, Kellner CP, Lopes DK, Raz E, Strbian D, Mannismaki L, Tomasello A, Tsogkas I, von Hessling A, Karwacki GM, Guzman R, Rommers N, Liebeskind DS, Arthur AS; SPINNERS investigators. ProSPective evaluation of the dIagnostic accuracy of siNe spiN non-contrast flatdEtectoR CT (FDCT) for the detection of intracranial hemorrhage in stroke patients - Protocol of a non-inferiority comparison to multi detector CT. PLoS One. 2025 Aug 28;20(8):e0330608. doi: 10.1371/journal.pone.0330608. eCollection 2025. | |
| 35318960 |
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Cross-sectional non-inferiority investigation with prospective open label data collection and blinded endpoint assessment
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Blinded assessment of outcome events through an independent Core-Lab
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| Non-contrast syngo DynaCT Sine Spin head scan and application software | Diagnostic Test | 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. |
|
| Chicago |
| Illinois |
| 60068 |
| United States |
| Nortshore University Health System | Chicago | Illinois | 60201 | United States |
| New York University Langone Health | New York | New York | 10016 | United States |
| Mount Sinai Health System | New York | New York | 10029 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Semmes Murphy Clinic | Memphis | Tennessee | 38120 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | United States |
| HUS | Helsinki | 00290 | Finland |
| CHRU de Tours | Tours | 37000 | France |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| University Hospital Basel | Basel | Switzerland |
| Inselspital Bern | Bern | Switzerland |
| Kantonsspital Luzern | Lucerne | Switzerland |
| Background |
| Petroulia VD, Kaesmacher J, Piechowiak EI, Dobrocky T, Pilgram-Pastor SM, Gralla J, Wagner F, Mordasini P. Evaluation of Sine Spin flat detector CT imaging compared with multidetector CT. J Neurointerv Surg. 2023 Mar;15(3):292-297. doi: 10.1136/neurintsurg-2021-018312. Epub 2022 Mar 22. |
| 29018132 | Background | Psychogios MN, Behme D, Schregel K, Tsogkas I, Maier IL, Leyhe JR, Zapf A, Tran J, Bahr M, Liman J, Knauth M. One-Stop Management of Acute Stroke Patients: Minimizing Door-to-Reperfusion Times. Stroke. 2017 Nov;48(11):3152-3155. doi: 10.1161/STROKEAHA.117.018077. Epub 2017 Oct 10. |
| 27998955 | Background | Leyhe JR, Tsogkas I, Hesse AC, Behme D, Schregel K, Papageorgiou I, Liman J, Knauth M, Psychogios MN. Latest generation of flat detector CT as a peri-interventional diagnostic tool: a comparative study with multidetector CT. J Neurointerv Surg. 2017 Dec;9(12):1253-1257. doi: 10.1136/neurintsurg-2016-012866. Epub 2016 Dec 20. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083302 | Hemorrhagic Stroke |
| D000083242 | Ischemic Stroke |
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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