Evaluating a new CT imaging method for detecting brain hemorrhages in stroke patients
ProSPective Evaluation of the dIagnostic Accuracy of siNe spiN Noncontrast Flat-dEtectoR CT (FDCT) for the Detection of Intracranial Hemorrhage in Stroke Patients
This study is testing a new type of CT scan to see if it can better detect brain bleeding in stroke patients compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 14 sites (Denver, Colorado and 13 other locations) |
| Trial ID | NCT05458908 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a new non-contrast imaging technique called syngo DynaCT Sine Spin for detecting intracranial hemorrhages in patients suspected of having a stroke. The goal is to determine if this method is as reliable as the traditional non-contrast MDCT imaging in identifying hemorrhagic strokes. By integrating imaging and endovascular therapy in the angiography suite, the study aims to reduce the time to treatment, which is critical for improving patient outcomes. Participants will undergo both imaging techniques to compare their sensitivity and specificity.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old presenting with symptoms of ischemic or hemorrhagic stroke within 24 hours of their last known well state.
Not a fit: Patients with severe metal artifacts on initial imaging or those who experience clinical deterioration before the second imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly shorten the time to treatment for stroke patients, potentially improving recovery outcomes.
How similar studies have performed: Previous studies have shown promising results with similar imaging approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado and 13 other locations
- Swedish Medical Center — Denver, Colorado, United States (Recruiting)
- AdvocateAurora Health — Chicago, Illinois, United States (Recruiting)
- Nortshore University Health System — Chicago, Illinois, United States (Recruiting)
- New York University Langone Health — New York, New York, United States (Recruiting)
- Mount Sinai Health System — New York, New York, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Semmes Murphy Clinic — Memphis, Tennessee, United States (Recruiting)
- University of Virginia Health System — Charlottesville, Virginia, United States (Recruiting)
- Hus — Helsinki, Finland (Recruiting)
- CHRU de Tours — Tours, France (Recruiting)
- Hospital Vall d'Hebron — Barcelona, Spain (Recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
- Inselspital Bern — Bern, Switzerland (Recruiting)
- Kantonsspital Luzern — Luzern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Marios-Nikos Psychogios, Prof Dr — University Hospital, Basel, Switzerland
- Study coordinator: Marios-Nikos Psychogios, Prof Dr
- Email: marios.psychogios@usb.ch
- Phone: +41 61 328 59 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.