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

• ClinicalTrials.gov Identifier: NCT01349946
• Recruitment Status: Completed
• First Posted: May 9, 2011
• Last Update Posted: April 14, 2016
• 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 Center; Swedish Health Services; National Institute of Neurological Disorders and Stroke (NINDS)
• Information provided by (Responsible Party): Gregory W Albers, Stanford University

Study Description

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.

Condition or disease
Cerebrovascular Accident

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 Design

• Study Type: Observational
• Actual Enrollment: 138 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Diffusion Weighted Imaging Evaluation for Understanding Stroke Evolution Study-2 (DEFUSE-2)
• Study Start Date: June 2008
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: December 2011

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. NIHSS Score [ Time Frame: 30 days ]

Secondary Outcome Measures :

1. Modifies Rankin Score [ Time Frame: 90 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

population includes those people with acute ischemic stroke

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

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

United States, Hawaii

The Queen

Honolulu, Hawaii, United States

United States, Illinois

Northwestern University

Chicago, Illinois, United States

United States, Oregon

Oregon Health Sciences University

Portland, Oregon, United States

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

United States, Utah

University of Utah

Salt Lake City, Utah, United States

United States, Washington

Swedish Hospital

Seattle, Washington, United States

Sponsors and Collaborators

Stanford University

University of Pittsburgh

Northwestern University

University of Utah

Oregon Health and Science University

St. Luke's Medical Center

Queen's Medical Center

Swedish Health Services

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Gregory W Albers; Stanford University

More Information

Publications of Results:

Lansberg MG, Straka M, Kemp S, Mlynash M, Wechsler LR, Jovin TG, Wilder MJ, Lutsep HL, Czartoski TJ, Bernstein RA, Chang CW, Warach S, Fazekas F, Inoue M, Tipirneni A, Hamilton SA, Zaharchuk G, Marks MP, Bammer R, Albers GW; DEFUSE 2 study investigators. MRI profile and response to endovascular reperfusion after stroke (DEFUSE 2): a prospective cohort study. Lancet Neurol. 2012 Oct;11(10):860-7. doi: 10.1016/S1474-4422(12)70203-X. Epub 2012 Sep 4.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Marks MP, Lansberg MG, Mlynash M, Olivot JM, Straka M, Kemp S, McTaggart R, Inoue M, Zaharchuk G, Bammer R, Albers GW; Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution 2 Investigators. Effect of collateral blood flow on patients undergoing endovascular therapy for acute ischemic stroke. Stroke. 2014 Apr;45(4):1035-9. doi: 10.1161/STROKEAHA.113.004085. Epub 2014 Feb 25.

• Responsible Party: Gregory W Albers, MD, Professor of Neurology, Stanford University
• ClinicalTrials.gov Identifier: NCT01349946
• Other Study ID Numbers: SU-02082011-7478; 10752; R01NS039325 ( U.S. NIH Grant/Contract )
• First Posted: May 9, 2011
• Last Update Posted: April 14, 2016
• Last Verified: April 2016

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases