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Diffusion Weighted Imaging Evaluation for Understanding Stroke Evolution Study-2 (DEFUSE-2)

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ClinicalTrials.gov Identifier: NCT01349946
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : April 14, 2016
Sponsor:
Collaborators:
University of Pittsburgh
Northwestern University
University of Utah
Oregon Health and Science University
St. Luke's Medical Center
Queen's Medical Centre
Swedish Health Services
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Gregory W Albers, Stanford University

Tracking Information
First Submitted Date May 5, 2011
First Posted Date May 9, 2011
Last Update Posted Date April 14, 2016
Study Start Date June 2008
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2011)
NIHSS Score [ Time Frame: 30 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01349946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 6, 2011)
Modifies Rankin Score [ Time Frame: 90 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diffusion Weighted Imaging Evaluation for Understanding Stroke Evolution Study-2 (DEFUSE-2)
Official Title Diffusion Weighted Imaging Evaluation for Understanding Stroke Evolution Study-2 (DEFUSE-2)
Brief Summary Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution Study 2 (DEFUSE 2) is a multi-center pilot study to determine if cerebral perfusion imaging can help identify which patients, who are ineligible for intravenous tissue plasminogen activator (iv tPA) therapy or have failed iv tPA therapy, are most likely to benefit from an endovascular clot removal procedure.
Detailed Description

Currently, the only approved therapy for acute stroke patients is a medication called tissue plasminogen activator (tPA). This medication is given as an intravenous infusion and can dissolve blood clots, thereby restoring blood flow to the brain. Early restoration of blood flow can prevent the permanent damage to the brain which typically occurs after a stroke. As a result, patients who achieve early restoration of blood flow have less disability than stroke patients in whom blood flow is not restored. Unfortunately, only a very small fraction of stroke patients is treated with tPA and benefits from tPA. Nationwide only 3 percent of stroke patients receive this therapy. The short treatment time-window is one of the main reasons that patients are not eligible for this treatment. Previously, tPA was only recommended in the 0 - 3 hour time window after stroke onset, but recent studies have shown efficacy our to 4 ½ hours. AHA guidelines now recommend treatment with iv tPA up to 4 ½ hrs. However, the number of stroke patients who will benefit from treatment remains small despite expansion of the time-window from 3 to 4 ½ hrs. This is the result of two main limitations of tPA. First, the majority of stroke patients present beyond the 4 ½ hour time-window and will therefore remain ineligible for treatment. Second, stroke patients who receive tPA do not always benefit because the treatment does not restore blood flow in all patients. Our research has shown that depending on the location of the blood clot, blood flow is restored in only 20 to 50% of stroke patients treated with tPA.

Patients with persistent blood vessel occlusions and no improvement in their clinical condition after receiving tPA or those arriving at the hospital outside the 4 1/2 hour time window routinely undergo mechanical clot removal to open an occluded blood vessel in the brain.

Mechanical clot removal increases the percentage of stroke patients who achieve recanalization, and as a result may increase the proportion of patients who have good clinical outcomes. However it is unclear for which stroke patients mechanical thrombectomy is most suitable. Although effective at removing blood-clots, it appears that mechanical clot retrieval is not beneficial for all patients. Whereas some patients benefit, others experience no effect, and yet others are likely harmed by mechanical clot retrieval. In order to avoid harm and maximize benefit it is important to know, prior to initiation of the mechanical clot retrieval procedure, if the procedure is likely to result in a clinical improvement. The investigators hypothesize that the response to mechanical clot retrieval can be predicted based on characteristics of an MRI scan obtained just prior to the retrieval procedure. The investigators hope to learn if new MRI techniques can help identify which patients are most likely to benefit from mechanical clot removal after receiving tPA.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population population includes those people with acute ischemic stroke
Condition Cerebrovascular Accident
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   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: May 12, 2014)
138
Original Estimated Enrollment
 (submitted: May 6, 2011)
130
Actual Study Completion Date December 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age 18 years and older
  2. Clinical diagnosis of ischemic stroke and a score of 5 or more points in the NIHSS.
  3. Planned to undergo intra-arterial (IA) therapy for acute hemispheric stroke (Either as primary therapy or as adjuvant therapy following intravenous tPA treatment)
  4. Planned to have a standard MRI including perfusion imaging and MR angiography of the circle of Willis (MRA) prior to IA therapy
  5. Intra-arterial thrombectomy can be started within 90 minutes of completion of MRI scan and within 12 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)
  6. Able to obtain informed consent (informed consent should be obtained prior to the baseline MRI scan).

Exclusion Criteria:

  1. Any pre-existing neurological illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke
  2. Pregnancy
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 NCT01349946
Other Study ID Numbers SU-02082011-7478
10752
R01NS039325 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gregory W Albers, Stanford University
Study Sponsor Stanford University
Collaborators
  • University of Pittsburgh
  • Northwestern University
  • University of Utah
  • Oregon Health and Science University
  • St. Luke's Medical Center
  • Queen's Medical Centre
  • Swedish Health Services
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Gregory W Albers Stanford University
PRS Account Stanford University
Verification Date April 2016