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Acute stroke trials and consent
  1. Mayank Goyal
  1. Correspondence to Dr M Goyal, Department of Radiology and Clinical Neurosciences, University of Calgary, 1403 29th Ave SW, Calgary, AB T2N2T9, Canada; mgoyal{at}ucalgary.ca

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“Consensus is what many people say in chorus but do not believe as individuals.” Eban, Abba

The world of intra-arterial therapy for acute ischemic stroke is currently in a state of flux. The IMS-3 trial (randomized trial comparing intravenous therapy with combined intravenous–intra-arterial therapy) was recently stopped prior to completion due to futility. A number of similar trials have either been started (THERAPY and others) or being planned (SWIFT-PRIME, ESCAPE and others). They hope to overcome some of the limitations faced by previous trials, including changes in imaging paradigms and improved devices.

We all know ‘time is brain’ in acute ischemic stroke, and infarcts grow over a period of time. This allows for selecting out patients who have relatively little irreversible damage (the core) and a sizeable penumbra for revascularization strategies. Over a period of time, various transportation, communication, imaging, and other technological advances have allowed for faster access to these revascularization strategies. The issue that I would like to discuss is the process of getting consent.

I was recently involved in taking care of a patient who was having an acute ischemic stroke due to left M1 occlusion. The patient fitted the criteria for participation in an acute trial comparing intravenous with combined intravenous–intra-arterial therapy. Following the protocol, the patient was started on intravenous tissue plasminogen activator (standard of care) and then we initiated the consent process for the trial. In spite of our best efforts, this took 40 min. This time delay in my opinion poses several problems. First, it introduces a bias against intra-arterial therapy by introducing a delay that effects only one arm of the study. Second, it has the potential to drive centers and individuals away from participation in trials, especially with the availability of an alternative approved. (I do want to point out that the …

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