Acute Ischemic Stroke
Conditions
Keywords
Stroke
Brief summary
The study objective for the Phase 2 of this research is to demonstrate and confirm the substantial time savings that can be obtained using cone beam computed tomography (CB-CT) for both complete image acquisition and rapid image reconstruction in a Direct to Angio paradigm (One Stop Shop) for selected acute ischemic stroke (AIS) patients.
Detailed description
Phase 2 of this research is aimed at validating the feasibility and time savings of bringing selected acute ischemic stroke patients with suspected large vessel occlusion directly on hospital arrival to the angiography suite, avoiding the emergency room and conventional MD-CT imaging. In order to make this phase of the study more robust and to reduce bias on image assessment we will prospectively randomize the patients in a 2:1 fashion to either direct to angio for CB-CT imaging or MD-CT imaging in the emergency room. A total of 60 CB-CT subjects and 30 MD-CT subjects will comprise this cohort. Entrance criteria will be identical to those in Phase 1, except the NIHSS must be greater than 8 which is clinically correlative with a likely large vessel occlusion and, since this is standard of care imaging for acute ischemic stroke, GFR will be removed as an exclusionary criteria. The Phase 1 of this research was registered to NCT03232151.
Interventions
DIAGNOSTIC_TESTC-Arm Cone Beam Computed Tomography
C-ARM CBCT angiogram and CBCT perfusion imaging using prototype software (SMART-RECON) can rapidly and accurately assess the cerebral blood flow maps in the setting of decreased blood flow to the brain (ischemic cerebrovascular events). This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the angiography suite.
DIAGNOSTIC_TESTMulti-detector Computed Tomography
Conventional, standard of care perfusion imaging for AIS
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single center, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with acute ischemic stroke presenting within 24 hours of onset 2. Patients that present with a large artery occlusion 3. Adults 18 years of age or older. 4. Patients of childbearing potential must not be pregnant. 5. National Institutes of Health Stroke Scale (NIHSS) of \<8 6. No severe co-morbidities
Exclusion criteria
1. Patients that are pregnant 2. History of severe renal disease (e.g. stage 4-5) 3. History of renal transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility measured as the amount of time from hospital arrival to the angiography suite | 1 visit (up to 120 minutes) | Phase 2 of the human subject study aims to further assess the feasibility as a measure the amount of time it takes to bring selected acute ischemic stroke patients with suspected large vessel occlusion directly on hospital arrival to the angiography suite, avoiding the emergency room and conventional MD-CT imaging. |
Countries
United States
Outcome results
None listed