Clinical trial NCT02409043: Neuronal and Glial Biomarkers in Stroke
Official title: Neuronal and Glial Biomarkers in Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Ischemic stroke
Hemorrhagic stroke
Biomarkers
Angiotensins
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals experiencing stroke symptoms who present at the University of Florida Shands Emergency Department or non-stroke control participants. These individuals will be invited to participate as study participants by a study representative within the first 24 hours after having a blood draw in the emergency department.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Serum ACE2 Activity Levels
timeFrame: Day 1
measure: Subacute Serum ACE2 Activity Levels
timeFrame: Day 3
measure: Follow-up Serum ACE2 Activity Levels
timeFrame: 8 weeks
Secondary outcomes:
measure: Initial NIH Stroke Scale Score
timeFrame: Day 1
measure: Recovery NIH Stroke Scale Score
timeFrame: Day 14
measure: Initial infarct size from brain imaging studies
timeFrame: Day 1
measure: Recovery infarct size from brain imaging studies
timeFrame: Day 14
measure: Initial modified Rankin Score
timeFrame: Day 1
measure: Recovery modified Rankin Score
timeFrame: Day 14
measure: Long-term modified Rankin Score
timeFrame: 3 months
measure: Acute Serum GFAP Levels
timeFrame: Day 1
measure: Subacute Serum GFAP Levels
timeFrame: Day 3
measure: Follow-up Serum GFAP Levels
timeFrame: 8 weeks
measure: Acute Serum UCH-L1 Levels
timeFrame: Day 1
measure: Subacute Serum UCH-L1 Levels
timeFrame: Day 3
measure: Follow-up Serum UCH-L1 Levels
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Harry Nick, PhD
role: PRINCIPAL_INVESTIGATOR
References: