ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-10-25
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05458908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Informed Consent as documented by signature or fulfilling the criteria for emergency or deferral consent
  2. * 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
  3. * Patient presenting within 24 hours of last seen well
  4. * 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
  5. * Age above 18 years
  6. * Agreement of treating physician to perform non-contrast syngo DynaCT Sine Spin
  1. * Severe metal artifacts on initial MDCT imaging
  2. * Planned invasive interventions between MDCT and FDCT scan
  3. * Clinical deterioration between MDCT and FDCT scan (i.e. an increase of the NIHSS of more than 4 points)
  4. * Evidence of an ongoing pregnancy prior to enrollment. A negative pregnancy test before enrollment is required for all women with child-bearing potential

Contacts and Locations

Principal Investigator

Marios-Nikos Psychogios, Prof Dr
PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Nitin Goyal, MD
STUDY_CHAIR
Semmes Murphey Clinic and University of Tennessee Health Sciences Center

Study Locations (Sites)

Swedish Medical Center
Denver, Colorado, 80210
United States
AdvocateAurora Health
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

Collaborators and Investigators

Sponsor: University Hospital, Basel, Switzerland

  • Marios-Nikos Psychogios, Prof Dr, PRINCIPAL_INVESTIGATOR, University Hospital, Basel, Switzerland
  • Nitin Goyal, MD, STUDY_CHAIR, Semmes Murphey Clinic and University of Tennessee Health Sciences Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-25
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-10-25
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • hemorrhagic stroke
  • ischemic stroke
  • large-vessel occlusions (LVO)
  • cone beam CT
  • intracranial hemorrhage
  • flat detector computer tomography (FDCT)

Additional Relevant MeSH Terms

  • Stroke