Effect of Epicardial Adipose Tissue Volume and Attenuation on Clinical Outcomes After Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Modified Rankin scale (mRS)
研究概览
简要总结
Excessive accumulation or abnormal distribution of adipose tissue is a recognized risk factor for ischemic stroke. However, the impact of overweight or obesity on clinical outcomes of ischemic stroke is uncertain. The proposition of obesity paradox in stroke patients makes secondary prevention ambiguous for patients with ischemic stroke and overweight or obesity. Body mass index (BMI) or abdominal visceral fat area was used to measure obesity in previous studies. Epicardial adipose tissue (EAT) is a unique visceral fat, which has higher expression of proinflammatory genes than subcutaneous fat and abdominal visceral fat. And inflammation is closely related to the prognosis of ischemic stroke. In this study, the investigators assume EAT volume or attenuation evaluated by chest computed tomography (CT) scan might affect the prognosis of patients with acute ischemic stroke (AIS). Patients with the first acute ischemic stroke will be stratified into tertile groups based on EAT volume or attenuation. The primary endpoint measure is the proportion of patients with a favorable recovery of nerve function deficiency assessed by Modified Rankin Scale （mRS≤2） at 90 days after the onset of symptoms. Secondary endpoints include the following: the percentage of functional recovery measured by the Barthel Index (BI) at day 90 after stroke onset, the propotion of clinical improvement (with an improvement of ≥ 4 points on the National Institute of Health Stroke Scale score or the resolution of the neurologic deficit) or neurological deterioration (with a decline by ≥ 4 points in the total National Institute of Health Stroke Scale score) at day 7 after stroke onset, incidence of hemorrhagic transformation and mortality within 7 days of symptom onset.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 80 years of old;
- •Acute ischemic stroke（AIS）is diagnosed by brain imaging, and this is the first ischemic stroke event;
- •Patient is admitted to hospital within 72 hours after stroke onset;
- •Modified Rankin scale score (mRS) ≤2 before onset;
- •Patient undergoes chest CT scanning during hospitalization;
- •Provision of written informed consent.
排除标准
- •Pregnant or nursing women;
- •Complicated with cerebral hemorrhage showed by cranial CT on admission;
- •Patient had brain tumor, intracranial aneurysm, arteriovenous malformation, or cerebral hemorrhage or underwent brain surgery in the past;
- •Severe cardiac, liver, pulmonary, or kidney disease, malignancy, severe coagulation dysfunction, and systemic organ dysfunction;
- •Failure to accomplish 7-day and 3-month follow up.
结局指标
主要结局
Modified Rankin scale (mRS)
时间窗: 90 days after stroke onset.
Assess patients' prognosis by the score of modified Rankin Scale. In the mRS, the lowest score is 0, the highest score is 6, and higher scores mean worse outcome. A score of 0 indicates the patients have no symptoms at all, and a score of 6 indicates the patients are dead. In this study, we evaluate patient's outcomes by the following criteria. A favorable outcome is defined as an mRS score of 0 to 2, an excellent outcome is defined as an mRS score of 0 to 1, whereas a poor outcome is defined as mRS\>2.
次要结局
- Barthel Index (BI)(90 days after stroke onset.)
- The change of NIHSS score(7 days after stroke onset.)
- Mortality(within 7 days of symptom onset)
- Hemorrhagic transformation(within 7 days of symptom onset)