Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project (CRISP) (CRISP)
|ClinicalTrials.gov Identifier: NCT01622517|
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : October 17, 2016
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||201 participants|
|Official Title:||Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
- NIHSS Score [ Time Frame: 30 Day ]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 ]90 day modified Rankin Score 0-2, 90 day modified Rankin distribution, and 90 day Rankin Score 0-1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622517
|United States, California|
|Stanford Hospital and Clinics|
|Stanford, California, United States, 94305|
|Principal Investigator:||Maarten G Lansberg, MD, PhD||Stanford University|