Ischemic Stroke Clinical Trial
Official title:
Phase 2 Study of Mild Hypothermia in Combination With Acute Cerebral Vascular Reperfusion in the Setting of Acute Ischemic Stroke
The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).This will be achieved by comparing patients that have undergone hypothermia to those that have not.
This study is designed to examine the safety and proof of concept of therapeutic hypothermia
prior to conventional revascularization in subjects experiencing acute ischemic stroke by
comparing the results to subjects who remain at normal body temperature (normothermic) and
proceed directly to reperfusion via conventional reperfusion intervention. The
investigational plan also examines the following outcomes in 85 subjects randomized to either
hypothermia or normothermia:
- Regulation of biomarkers indicative of ischemia-reperfusion injury
- Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM)
protocol MRI as a surrogate imaging biomarker
- Incidence of hemorrhagic conversion post reperfusion
- Neurologic function at 90 days post acute ischemic stroke. The results of this study
will be used to power a definitive phase III clinical trial evaluating the combination
of hypothermia and revascularization versus reperfusion alone.
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