We are studying whether visual field testing can be completed using a virtual reality headset with software designed and installed to cause a "blink to threat" response. A positive "blink to threat" response implies an intact visual field. Subject volunteers will have both in person "blink to threat" visual field testing and headset "blink to threat" visual field testing. We are testing the accuracy, timing, tolerability and satisfaction (of both examiner and patient) with the use of virtual reality visual field testing.
The purpose of this research study is to see whether ticagrelor and aspirin or rivaroxaban and aspirin compared to clopidogrel and aspirin will have the most success in preventing another stroke, bleed in the brain, or death in participants who have already had a stroke from a narrowed brain artery.
An emergency care research study of bleeding in the brain is to be performed in this area.
The Medical University of South Carolina is joining researchers at more than 100 other hospitals across the United States and other countries to conduct a research study of bleeding in the brain called FASTEST. This research study may affect you or someone you know. FASTEST is a research study involving patients who have had bleeding in the brain, also called intracerebral hemorrhage (ICH).
ICH occurs when a weakened blood vessel in the brain breaks and bleeding accumulates in the brain. Most of this bleeding occurs within a few hours of onset of symptoms. The brain injury from ICH is usually very severe, over 40% of people with ICH die within a month, and only 20% can independently care for themselves after 6 months.
There is currently no treatment for ICH that is scientifically proven to improve outcome. The FASTEST research study is being done to determine if recombinant Factor VIIa (rFVIIa), a protein that our body makes to stop bleeding at the site of injury to a blood vessel, can slow bleeding in the brain and improve outcome. rFVIIa is approved for treatment of bleeding in patients who have inherited lack of clotting factors but is not approved for treatment of ICH.
Participants in the FASTEST research study are placed at random, that is by chance, into one of 2 groups. They have an equal chance of getting rFVIIa or placebo (no active ingredient). One group receives rFVIIa intravenously over 2 minutes within two hours of onset of symptoms and the other group receives placebo. We do not know if rFVIIa is better than placebo for patients with bleeding in the brain. The results of the FASTEST research study will help doctors discover if rFVIIa improves outcome in patients with bleeding in the brain. Medical care otherwise will be identical for the two treatment groups, including close management of blood pressure and care within an intensive care unit. Some patients will be enrolled without consent if a family member or representative is not rapidly available.
Before the research study starts, we will consult with the community and need your input as this research may affect you or someone you know, and we need to find out ahead of time what the community thinks about it. Below are links to the the FASTEST site for more information about this research study and how to give your feedback. There are no known risks involved in participating in this survey and your participation is completely voluntary. THANK YOU for your help and time in completing this survey:
Click here for more information or to decline participation in this research study: https://nihstrokenet.org/fastest/home
Click here to access the survey to provide feedback and ask questions:
OR To contact our research study staff at (843-792-3020).
Primary Investigator: Dr. Christine Holmstedt
Study Coordinators: Vicki Streets or Cheryl Grant
CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials. One trial will assess treatment differences between intensive medical management alone compared to carotid endarterectomy procedure plus intensive medical management. The parallel trial will assess treatment differences between intensive medical management alone compared to carotid artery stenting plus intensive medical management. Intensive medical management will involve control of blood pressure, LDL cholesterol, cigarette smoking, and other vascular risk factors.