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Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project (CRISP) (CRISP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01622517
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : October 17, 2016
Sponsor:
Collaborators:
Saint Luke's Health System
University of Pittsburgh
Emory University
Chatanooga Center for Neurological Research
University of Miami
Information provided by (Responsible Party):
Maarten Lansberg, Stanford University

Tracking Information
First Submitted Date June 15, 2012
First Posted Date June 19, 2012
Last Update Posted Date October 17, 2016
Study Start Date September 2011
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2012)
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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01622517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 12, 2012)
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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project (CRISP)
Official Title Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population acute ischemic stroke patients
Condition Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 13, 2016)
201
Original Estimated Enrollment
 (submitted: June 15, 2012)
200
Actual Study Completion Date February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. be 18 or older;
  2. have a clinical diagnosis of ischemic stroke and a score of 5 or more points on the NIHSSS;
  3. be scheduled to undergo intraarterial (IA) therapy for acute hemispheric stroke (either as primary therapy or as adjuvant therapy following intravenous tPA treatment);
  4. be scheduled to have a standard CT including perfusion imaging and CT angiography of the circle of Willis (CTA) prior to IA therapy;
  5. begin intra-arterial thrombectomy within 90 minutes of completion of the CT scan and within 18 hours of symptom onset. (Start of IA therapy is defined as the time of insertion of the femoral artery sheath; Time of brain scan is defined as the time that the scan is completed); and
  6. have provided informed consent.

Exclusion Criteria:

  1. have any pre-existing illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke;
  2. are pregnant.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01622517
Other Study ID Numbers 22227
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maarten Lansberg, Stanford University
Study Sponsor Stanford University
Collaborators
  • Saint Luke's Health System
  • University of Pittsburgh
  • Emory University
  • Chatanooga Center for Neurological Research
  • University of Miami
Investigators
Principal Investigator: Maarten G Lansberg, MD, PhD Stanford University
PRS Account Stanford University
Verification Date October 2016