Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project (CRISP) (CRISP)
The overall goal of the CTP to predict Response to recanalization in Ischemic Stroke Project (CRISP) is to develop a practical tool to identify acute stroke patients who are likely to benefit from endovascular therapy.
The project has two main parts. During the first part, the investigators propose to develop a fully automated system (RAPID) for processing of CT Perfusion (CTP) images that will generate brain maps of the ischemic core and penumbra. There will be no patient enrollment in part one of this project.
During the second part, the investigators aim to demonstrate that physicians in the emergency setting, with the aid of a fully automated CTP analysis program (RAPID), can accurately predict response to recanalization in stroke patients undergoing revascularization. To achieve this aim the investigators will conduct a prospective cohort study of 240 consecutive stroke patients who will undergo a CTP scan prior to endovascular therapy. The study will be conducted at four sites (Stanford University, St Luke's Hospital, University of Pittsburgh Medical Center, and Emory University/Grady Hospital). Patients will have an early follow-up MRI scan within 12+/-6 hours to assess reperfusion and a late follow-up MRI scan at day 5 to determine the final infarct.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project|
- NIHSS Score [ Time Frame: 30 Day ] [ Designated as safety issue: No ]A "favorable clinical response", defined as an 8-point or more improvement on the NIH score when comparing the baseline score to the 30-day score or a 30-day NIH score of 0-1, will be the primary endpoint for the study
- modified Rankin Score [ Time Frame: 90 day ] [ Designated as safety issue: No ]90 day modified Rankin Score 0-2, 90 day modified Rankin distribution, and 90 day Rankin Score 0-1
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622517
|United States, California|
|Stanford Hospital and Clinics||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Stephanie M Kemp, BS 650-723-4481|
|Principal Investigator:||Maarten G Lansberg, MD, PhD||Stanford University|