The Potential Effect of Omega3 Supplement in Fish Oil on Infarced Areas in the Brain and Improvement of Neurological Functions fo Ischemic Stroke Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Improvement of neurological symptoms and functions (Severity)
研究概览
简要总结
In this trial, The investigators are going to investigate the improvement of neurological functions and infarced area of the brain in ischemic stroke patients after ingestion of omega 3 products that have high concentrations of DHA and EPA in comparison to control group. The study will assess the improvement by computerized calculation of the size of the infarcted area before and after the intervention and neurological assessment tools. The researchers will follow the scientific and ethical regulations prevent any harmful effect on recruited subjects.
详细描述
Introduction and Background According to the Center of Disease Control and Prevention, stroke is the 5th leading cause of mortality in the US, and a leading cause of significant long-term disability where almost 50% of stroke survivors, age 65 and above, suffer from disabling decrease in mobility. In its simplest form, an ischemic stroke is a decrease in the blood flow to a certain area in the brain, due to a clot, stenosis or other cause, which lasts long enough to cause permanent cellular injury and death and by extension, disability [1]. However, much more goes into that process.
The decreased blood flow to the tissue leads to the primary insult caused by ischemia which leads to direct and immediate cell death. Meanwhile, the tissue surrounding this ischemic area gets affected by the inflammation in the ischemic area, but maintains its viability and is called the penumbra. Later on, this penumbra gets affected by the immune response and toxic inflammatory mediators released in the ischemic area. Which ultimately results in axonal structural changes and subsequent neuronal damage (secondary insult.) The main attention of this paper is looking into the prevention of secondary insult and preserving the penumbra which carries a neurorestorative capacity that is diminished by the inflammatory response and the possibility of restoring the damaged area by neurogenesis as will be explained later. As a result, improving the disability caused by the ischemic event [2].
Currently, the only FDA approved treatments of stroke are Tissue Plasminogen Activator (tPA) and Trevo which is a clot removal device, introduced in 2012. However, the group harvesting the benefits of those treatments are fairly limited. For example, tPA has many contraindications in addition to a narrow window of application of 4.5 hours from the start of symptoms. Trevo can only be used within 6 hours as well (extended to 24h in certain cases) [3]. Furthermore, a major downside that plagues these interventions is the ischemia/reperfusion injury. I/R injury is characterized by reduced vascular relaxation and perfusion, increased macromolecular permeability and an intense inflammatory response derived by reactive oxygen species (ROS) from the ischemic area [2].
Other interventions are being currently studied in the preclinical setting which is aimed at enhancing and supporting the activity of neurons and neural progenitor cells and promoting long-term functional recovery. Rather than concentrating on restoring blood flow, these interventions are aimed towards inducing neuroprotection and saving brain function in the long term. One such example, is omega-3 essential polyunsaturated fatty acids (PUFA n3) specifically docosahexaenoic acid (DHA, 22:6, n-3) and eicosapentaenoic acid (EPA, 20:5, n-3), to a lesser extent. They have been shown to have a profound effect on decreasing the neuroinflammation in the brain tissue of animal models after an acute stroke in addition to its positive effects on cognitive function and neurodevelopment [4,5]. Furthermore, studies conducted on mice such as the one conducted by José Pedro De La Cruz et al has shown great neuroprotective qualities and a significant reduction in post-stroke neuroinflammation using olive oil and acetylsalicylic acid [6].
Considering all that which have been mentioned in our introduction, the investigators have set several objectives for this paper. First of all, studying the effects of using * omega-3* as a safe and effective measures to prevent neuroinflammation after an ischemic event and how can this affect the process of neurogenesis and subsequently and effect on patient disability by using olive oil as one of the resources of omega-3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted ischemic occlusive stroke after successful reperfusion therapy - Stabilized in ICU or the inward
- •Attack started 48 hours or less
- •Can be fed by nasogastric tube or by himself
- •MRI imaging was taken in the first 24 hours and CT [10]
排除标准
- •Hemorrhagic stroke
- •Non-occlusive hypoxic brain
- •Global cerebral ischemia
- •Transient ischemic attack
- •Non-scanned by MRI or CT in the first 48 hours of onset
- •Non-reperfused stroke patient or non-successful reperfusion therapy
- •Deteriorating cases and not stabilised patients
- •Attack exceeded 48 hours since onset
- •Non-tolerated patients to feeding (NPO)
- •Unstable source of thrombi (e.g. vegetation heart valves, unstable carotid atherosclerosis..etc)
- •Presence of any coagulopathy
- •Sickle cell anaemia
- •Risk for shock ( e.g. septic shock, hypovolemic shock, cardiogenic shock...etc) - Time of onset is not reliably known
- •Suspected non-stroke diagnosis
- •Significant concurrent medical condition
- •Significant pre-existing disability ( will be excluded from neurological scoring assessment not CT MRI assessment)
- •Liver disease
结局指标
主要结局
Improvement of neurological symptoms and functions (Severity)
时间窗: after 3 months of intervention
Assessed by National Institutes of Health Stroke Scale. The scale range is from 0 to 42 as following: * 0 No stroke symptoms * 1-4 Minor stroke * 5-15 Moderate stroke * 16-20 Moderate to severe stroke * 21-42 Severe stroke
Brain Infarction size
时间窗: after 3 months of intervention
will be assessed by square centimetres on MRI scan
Improvement of neurological symptoms and functions (Dependence)
时间窗: after 3 months of intervention
Assessed by the modified Rankin Scale. The scale consists of degrees from 0 to 6 as following: 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability 3. - Moderate disability. 4. - Moderately severe disability 5. - Severe disability 6. - Dead.
次要结局
未报告次要终点
研究者
Nouf Al Mansour
Subspecialty Consultant Neurologist And Stroke Specialist
King Fahad Medical City
