The Recurrence Study
Từ khóa
trừu tượng
Sự miêu tả
Patient admitted to the stroke service with acute stroke and TIAs will be eligible for the study. The study will enroll patients at Hamad General Hospital in the setting of the Stroke Ward.
The investigators anticipate approximately 300 patients to be enrolled based on the number of strokes that are admitted to the HGH stroke service every year.
The research primarily involves the evaluation of best medical therapy, and the incidence of biomarkers in the recurrence and progression of the disease in a high-risk cohort of stroke and TIA patients.
After obtaining informed consent the subjects medical information such as medical history will be collected in the case record forms. subjects MRI studies ( performed as standard of care) will be analyzed with a special software to determine the extent and volume of the most recent infarction. The degree of previous white matter damage and any incidental previous strokes will be recorded. MRI brain is a routine imaging technique in the care of stroke patients. Corneal confocal microscopy (CCM) imaging will be ordered for subjects whose standard of care attending physicians havent ordered for them. Some Stroke patients at HGH are ordered CCM if considered necessary by their physician. For the purpose of the study, the investigators would like to order CCM for all the subjects. CCM can be perfomed at anytime within the first month of recruitment into the study so the investigators will have it scheduled as it is convenient to the subjects within the month. The investigators hypothesize that corneal nerve loss may be driven by the same common vascular risk factors which may lead to stroke and thereby provide a surrogate for cerebral neuronal loss and hence pre-stroke 'neuronal reserve'. Hence CCM may allow us to identify the extent of risk factor burden. Furthermore, the quantification of corneal nerves may allow the identification of those with a lower pre-stroke neuronal reserve, and hence may suffer worse neurological outcomes following a stroke.
The subjects will be offered the best medical treatment for stroke, risk factors will be assessed by a team of stroke neurologists and nurse specialists. There will be regular follow-up visits at 1 month+/- 7 days, 3 months ( telephonic follow up only) and 1 year (clinical and repeat MRI brain).
After consent, serum and plasma will be obtained at onset of participation: Sample A (at onset), Sample B: within less than 48 hours, and Sample C:at 30 day +/- 1 week follow up visit. The blood samples will assist the team to study pro-coagulant and inflammatory markers. The team will require 10 mL ( 3 vials, 2 of which will have 4 mL of blood and the 3rd will have 2 mL) of blood on the aforementioned three days.
The blood , plasma and urine samples will undergo testing at the Neuroscience lab at iTRI, HMC, Qatar. A comparison between the different circulating biomarkers, proteins, DNA and metabolites might provide useful information on correlation between diabetes ( and other risk factors) and stroke. A variety of techniques are to be used including the following
1. Metabolites (metabolomics) High performance liquid chromatography (HPLC) and Liquid chromatography mass spectroscopy (LC/MS/MS) for detection of branching amino acids, glycine, aromatic amino acids and neurotransmitters.
Molecular biology techniques for detection of cytokines and interleukins Measurement of microparticles and their content in human serum via flow cytometry ELISA for detection of reactive oxygen species SDS-PAGE for detection of cysteine proteases and inflammatory response proteins vWF testing to be done in Hamad General Hospital laboratory
2. Proteomics In the proposed study, th einvestigators will use a proteomics based approach to perform a global proteomic profiling using the plasma from patients reportedly suffering from ischemic stroke and are at the same time diabetic. The proteomic profiling could lead to the identification of set of novel proteins that can be used as potential markers involved in the ischemic stroke development in patients with diabetic condition. By using a gel-based proteomics approach, the plasma proteins will be subjected to pre-fractionation by SDS-PAGE analysis followed by in-gel tryptic digestion and the purified peptides will be analyzed by Liquid Chromatography coupled to tandem Mass Spectrometry. The sequenced peptides will be searched against the available database to obtain protein identifications.
Samples required: Serum, plasma and urine samples. Plasma can be retrieved from whole blood in EDTA sample bottles after centrifugation. Serum can be retrieved from whole blood in plain sample bottles after centrifugation. Urine can be collected in plain sample bacti bottles.
ngày
Xác minh lần cuối: | 07/31/2017 |
Đệ trình đầu tiên: | 06/03/2017 |
Đăng ký ước tính đã được gửi: | 08/07/2017 |
Đăng lần đầu: | 08/08/2017 |
Cập nhật lần cuối được gửi: | 08/07/2017 |
Cập nhật lần cuối đã đăng: | 08/08/2017 |
Ngày bắt đầu nghiên cứu thực tế: | 02/16/2016 |
Ngày hoàn thành chính ước tính: | 02/16/2018 |
Ngày hoàn thành nghiên cứu ước tính: | 05/16/2018 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Diagnostic Test: The study group
Diagnostic Test: The study group
Other: Blood sample
Giai đoạn
Nhóm cánh tay
Cánh tay | Can thiệp / điều trị |
---|---|
Experimental: The study group The intervention to be evaluated is the patient response and compliance to best medical treatment and prevention of recognized stroke risk factors and the recurrence of stroke and TIA in the study group and its relation to the incidence of blood biomarkers.
The Nurse practitioners at the stroke ward will withdraw blood and collect urine samples from all the subjects. All the subjects from the study group will have 2 follow up visits (1 month and at 1 year) at HGH and one telephonic follow up at 3 months. The blood samples will be used to monitor blood inflammatory biomarker levels. At the beginning of the study, all subjects will have an MRI scan to assess plaque volume (this MRI scan will be ordered as part of the standard of care as per the policies applied to all stroke patients). MRI scans will be repeated at one year to assess any progression or regression in the plaque volume of the subjects.
No drugs will be administered to the patients for the purpose of our study. | Diagnostic Test: The study group Retinal imaging will be ordered for all subjects in the study group. Corneal |
Other: Control The control group will have blood work done to assess their blood inflammatory biomarkers but not the corneal confocal imaging. |
Đủ tiêu chuẩn
Tuổi đủ điều kiện để học | 18 Years Đến 18 Years |
Giới tính đủ điều kiện để nghiên cứu | All |
Chấp nhận tình nguyện viên lành mạnh | Đúng |
Tiêu chí | Inclusion Criteria: - Subjects 18 years and older - Subjects willing to give consent and agree to regular follow up visits; - Male/Female patients of all nationalities admitted to HGH or seen in the Stroke Ward/ TIA clinics with a confirmed diagnosis of acute stroke and TIA, confirmed on the initial standard of care ordered MRI imaging. - Stroke onset is less than 48 hours. Exclusion Criteria: - Pregnant women or individuals with cognitive disabilities. - individuals with onset > 48 hours. |
Kết quả
Các biện pháp kết quả chính
1. Circulating Biomarkers [Blood samples will be assessed at baseline]
2. Circulating biomarkers [Blood samples will be extracted at 48 hours]
3. Circulating biomarkers [Blood samples will be extracted at 1 month+/- 7 days]
Các biện pháp kết quả thứ cấp
1. Progression of disease [1 year]