the Predictors of Different ECASS-based Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients Treated With Alteplase
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 716
- 试验地点
- 1
- 主要终点
- the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group
研究概览
简要总结
The investigators evaluated the impact of AF on different subtypes of post-alteplase hemorrhagic transformation of brain infarction.
详细描述
Investigators conducted a prospective cohort study between July 2021 and July 2023. They screened 1550 patients who presented with AIS and received alteplase and included 716 AIS patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination, and specific brain imaging results and treated with alteplase within four and half hours of stroke onset.
The investigators assessed the patients' follow-up brain imaging to detect the subtypes of hemorrhagic transformation after receiving alteplase.
The study consisted of two distinct groups. The first group consisted of 454 patients who did not experience hemorrhagic infarction, while the second group comprised 262 patients who experienced hemorrhagic infarction.
The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors different types of AF were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigators enrolled individuals of both genders, aged between 18 and 75,
- •All patients had acute first-ever embolic ischemic stroke and were eligible for thrombolysis.
- •All patients had Atrial fibrillation
排除标准
- •The investigators excluded patients who had alteplase contraindications
- •The investigators excluded patients who did not receive the total dose of alteplase for any reason.
- •The investigators excluded patients who had a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis)
- •The investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or MRI brain findings.
- •The investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks.
- •The investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest.
研究组 & 干预措施
Hemorragic transformation group
262 acute ischemic stroke (AIS) patients who had a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase.
干预措施: Alteplase (Drug)
non-hemorragic transformation group
454 acute ischemic stroke (AIS) patients did not have a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase
干预措施: Alteplase (Drug)
结局指标
主要结局
the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group
时间窗: 48 days
The investigators will evaluate the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group
次要结局
- the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group(48 hours)
- the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group(48 hours)
- the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group(48 hours)
研究者
Mohamed G. zeinhom, MD
principal investigator
Kafrelsheikh University