NCT05458908Completed
ProSPective Evaluation of Non-contrast sINe spiN Flat-dEtectoR CT 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
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 252 (actual)
- First submitted
- 20 Jun 2022
- Start date
- 25 Oct 2022
- Primary completion date
- 11 Nov 2025
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Stroke
- NCT number
- NCT05458908
What you commit to
- Study type: Interventional
- Participants enrolled: 252
- From 25 Oct 2022 to the primary completion date, 11 Nov 2025
- 14 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of an ongoing pregnancy prior to enrollment. A negative pregnancy test before enrollment is required for all women with child-bearing potential
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Kantonsspital Luzern Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| HUS Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| CHRU de Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Nortshore University Health System Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| AdvocateAurora Health Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Swedish Medical Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Semmes Murphy Clinic Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| New York University Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Health System Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.