Neuronal and Glial Biomarkers in Stroke
Ключові слова
Анотація
Опис
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.
Дати
| Востаннє перевірено: | 08/31/2017 |
| Перший поданий: | 02/01/2015 |
| Орієнтовна реєстрація подана: | 03/30/2015 |
| Опубліковано вперше: | 04/05/2015 |
| Останнє оновлення надіслано: | 09/06/2017 |
| Останнє оновлення опубліковано: | 09/10/2017 |
| Фактична дата початку навчання: | 06/30/2014 |
| Розрахункова дата первинного завершення: | 11/30/2015 |
| Розрахункова дата завершення дослідження: | 11/30/2015 |
Стан або захворювання
Втручання / лікування
Other: Blood draw
Other: Stroke blood draw
Фаза
Групи рук
| Рука | Втручання / лікування |
|---|---|
| Control Non-stroke participants. Blood drawn for analysis of biomarkers. | |
| Ischemic Stroke Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, and MRI infarct size assessed in hospital. 3 month modified Rankin scale score collected by phone interview. | |
| Hemorrhagic Stroke Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, and MRI infarct size assessed in hospital. 3 month modified Rankin scale score collected by phone interview. | |
| Stroke Mimic Participants presenting at the University of Florida Shands Emergency Department with signs and symptoms resembling a stroke, but which are determined to be from another cause. Blood drawn during initial emergency room evaluation. |
Критерії прийнятності
| Вік, придатний для навчання | 18 Years До 18 Years |
| Стать, яка підходить для вивчення | All |
| Метод відбору проб | Non-Probability Sample |
| Приймає здорових добровольців | Так |
| Критерії | 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 |
Результат
Заходи первинного результату
1. Acute Serum ACE2 Activity Levels [Day 1]
2. Subacute Serum ACE2 Activity Levels [Day 3]
3. Follow-up Serum ACE2 Activity Levels [8 weeks]
Заходи вторинного результату
1. Initial NIH Stroke Scale Score [Day 1]
2. Recovery NIH Stroke Scale Score [Day 14]
3. Initial infarct size from brain imaging studies [Day 1]
4. Recovery infarct size from brain imaging studies [Day 14]
5. Initial modified Rankin Score [Day 1]
6. Recovery modified Rankin Score [Day 14]
7. Long-term modified Rankin Score [3 months]
8. Acute Serum GFAP Levels [Day 1]
9. Subacute Serum GFAP Levels [Day 3]
10. Follow-up Serum GFAP Levels [8 weeks]
11. Acute Serum UCH-L1 Levels [Day 1]
12. Subacute Serum UCH-L1 Levels [Day 3]
13. Follow-up Serum UCH-L1 Levels [8 weeks]
