Neuronal and Glial Biomarkers in Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | December 2015 |
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.
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.
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
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