Neuronal and Glial Biomarkers in Stroke
Neuronal and Glial Biomarkers in Stroke
The purpose of this research study is to determine if there are molecules in the blood that
 indicate when a person has had a stroke, and what type of stroke they have had, so that
 appropriate treatment may be begun as soon as possible. This study is also being conducted to
 determine whether these molecules can help to predict long-term health following stroke. Some
 of these potential molecules, also called biomarkers, include Neuronal biomarker ubiquitin
 C-terminal hydrolase-L1 (UCH-L1), Glial markers such as glial fibrillary acidic protein
 (GFAP), and a neuroprotective enzyme called angiotensin converting enzyme 2 (ACE2), which has
 activity that has been shown to be helpful cardiovascular disease and shown to be altered in
 animal models of acute stroke, where it is also shown to provide neuronal protection.
Research Plan Participants will be recruited from those presenting at Shands University of
 Florida (UF) hospital emergency room within the early hours after symptom onset, during which
 time a blood draw will be taken. Either in the emergency room, intensive care unit, or
 general hospital ward, a member of the study team will obtain informed consent for study
 participation within 24 hours of the first blood draw. The study team will provide the
 participant or legally authorized representative (LAR) with the consent form to read and will
 explain the study to the participant or LAR using the consent form as a guide. Time will be
 given to allow the participant or LAR to read the consent form and any questions will be
 answered. If the participant or LAR agrees to participate, then the study team member will
 have the participant sign the consent form and a copy of the signed form will be given for
 participants' records.

 Study procedure: Information will be collected from medical records to determine the type and
 severity of stroke that the participant had and the time of stroke onset. Three 10cc samples
 of blood will be drawn from 90 participants with stroke (45 with ischemic stroke and 45 with
 hemorrhagic stroke). Samples of blood will also be drawn from 45 controls and 45 patients
 with stroke mimics, clinical symptoms that could be stroke but are determined to be due to
 another cause (e.g. transient ischemic attack). The first 10cc will be drawn within 18 hours
 of stroke onset and the second will be drawn 72 hours following stroke onset. The third will
 be obtained at the UF Neurology outpatient clinic 2-8 weeks after stroke. The first blood
 sample will be drawn during the initial evaluation in the ER prior to obtaining informed
 consent. This is due to the hectic ER environment and the need for the participant or LAR to
 be making serious medical decisions during this initial evaluation; factors which make this a
 non-ideal time to perform the informed consent process. The blood sample will then be stored
 using only the de-identified participant number for identification. Once the participant's
 condition has stabilized and no other serious medical decisions are being made, a study team
 member will approach the participant or LAR for the informed consent process as described
 above.

 If the informed consent is obtained within 24 hours of obtaining the first blood sample then
 the participant will be enrolled in the study, the stored blood sample will be kept for
 further processing, the second and third blood samples will be drawn as previously described
 and testing for the aforementioned panel of biomarkers will be performed on the blood
 samples. If the participant or LAR declines to participate in the study or if informed
 consent is not obtained within 24 hours of the obtaining the first blood sample: 1) the
 stored blood sample will not be used for any purpose, 2) the stored blood sample will be
 completely destroyed within 24 hours of knowledge that the participant will not participate
 in the study and 3) no further blood samples will be obtained. Finally, participant's will be
 asked to complete a brief (less than 5 minute) phone survey 3 months after stroke to assess
 long-term stroke disability.
Inclusion Criteria:

 -  Stroke, ischemic or hemorrhagic, is confirmed by clinical and/or imaging evidence

 -  For control participants, no acute or recent stroke

 Exclusion Criteria:

 -  Onset of stroke symptoms cannot be confirmed to be less than 18 hours