Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02409043
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2015-02-02
Brief Title:
Neuronal and Glial Biomarkers in Stroke
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Neuronal and Glial Biomarkers in Stroke
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 participants 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 participants will be asked to complete a brief less than 5 minute phone survey 3 months after stroke to assess long-term stroke disability
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 eg 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 participants 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 participants will be asked to complete a brief less than 5 minute phone survey 3 months after stroke to assess long-term stroke disability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None