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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Stanford University
Sponsor:
Collaborators:
Saint Luke's Health System
University of Pittsburgh
Emory University
Information provided by (Responsible Party):
Maarten Lansberg, Stanford University
ClinicalTrials.gov Identifier:
NCT01622517
First received: June 15, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

acute ischemic stroke patients

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622517

Locations
United States, California
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Stephanie M Kemp, BS    650-723-4481      
Sponsors and Collaborators
Stanford University
Saint Luke's Health System
University of Pittsburgh
Emory University
Investigators
Principal Investigator: Maarten G Lansberg, MD, PhD Stanford University
  More Information

No publications provided

Responsible Party: Maarten Lansberg, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01622517     History of Changes
Other Study ID Numbers: 22227
Study First Received: June 15, 2012
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014