Acute Stroke Clinical Trial
Official title:
Evaluation Of Risk Of Recurrence Of Stroke And Vascular Events In Patients Presenting With Acute Stroke And Tia To Hamad General Hospital
The primarily goal of the research is to better understand progression of disease in patients
who present with an acute stroke to the Hamad General Hospital (HGH) stroke and Transient
Ischemic Attack (TIA) clinic. The investigators are specifically interested in patients who
have diabetes and have a stroke.
The patients enrolled into the research will have detailed clinical evaluation and their
imaging studies (MRI and Doppler) will be reviewed. After informed consent, subjects will be
examined in the stroke Ward /TIA clinic upon recruitment, and later at less than 48 hours of
recruitment (blood extraction and urine samples) and for follow up visits at 1 month+/-7 days
(clinical evaluation and to extract blood and urine samples), at 3 months (telephonic
conversation only) and at 1 year (clinical and repeat MRI brain).
During the initial visit at the ward the investigators will collect serum and plasma for
proteomic and metabolomic studies. These will be repeated at less than 48 hours and at 1
month+/-7 days. Investigators will test the effects of risk factors such as diabetes/stroke
on the endothelial procoagulant and inflammatory state at onset and evaluate if best medical
control leads to improvement in such markers.The repeated studies will determine if better
management and presence of certain blood biomarkers can predict or translate to slower
progression of disease and correlate it with clinical status.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 17, 2018 |
Est. primary completion date | February 17, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Qatar | The Neuroscience Institute, Hamad Medical Corporation | Doha |
Lead Sponsor | Collaborator |
---|---|
Hamad Medical Corporation |
Qatar,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Circulating Biomarkers | The primary outcome will be to assess blood inflammatory biomarker levels in both the study group as well as the controls at baseline | Blood samples will be assessed at baseline | |
Primary | Circulating biomarkers | To assess blood inflammatory biomarker levels in the study group at less than 48 hours | Blood samples will be extracted at 48 hours | |
Primary | Circulating biomarkers | To assess blood inflammatory biomarker levels in the study group at less than 1 month+/- 7 days | Blood samples will be extracted at 1 month+/- 7 days | |
Secondary | Progression of disease | We will measure the plaque volume in the stroke patients by conducting an MRI scan at admission to the hospital and later repeating it at year 1. We will also utilize corneal confocal imaging as a surrogate procedure to assess the progression of stroke and other vascular events. | 1 year |
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