Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke (MCTAHS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- modified Rankin Scale (mRS)
研究概览
简要总结
Acute hemorrhagic stroke is a series of neurosurgical diseases characterized by bleeding with high morbidity and mortality. It accounts for about 20% of all strokes worldwide and mainly includes subtypes such as intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH). Multimodal computed tomography including non-contrast computed tomography, computed tomography angiography and computed tomography perfusion, is of great important in understanding pathophysiological changes, evaluating prognosis and guiding interventions in these diseases.
详细描述
Study overview: The data of the population in the MACTAHS study will be prospectively collected. The CT strategies for acute hemorrhagic stroke are mainly three categories: non-contrast computed tomography, computed tomography angiography and computed tomography perfusion. Each participants will be followed at least until 1 year after discharge. Finally, investigators will clarify the prognostic value of multimodal CT for patients with acute hemorrhagic stroke.
Sample size: About 10000 patients will be enrolled in this study. All the population will be expected to undergo non-contrast computed tomography, computed tomography angiography and computed tomography perfusion.
Study endpoints: Neurological functional outcomes, delayed ischemia and infarction, recurrent bleeding, cognition and emotional dysfunction, systemic in-hospital systemic complications, rehabilitation and recovery status will be evaluated and follow-up would be completed.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 18, ≤ 85 years;
- •presence with hemorrhagic stroke
排除标准
- •with a history of previous history of ischemic/hemorrhagic stroke;
- •admission to the emergency department more than a week after symptom onset;
- •serious medical history or existing comorbidities;
- •physical disability due to previous diseases;
- •prior treatment such as external ventricular drainage, digital subtraction angiography and lumbar puncture in other institution;
- •poor original image quality;
- •incomplete follow-up.
结局指标
主要结局
modified Rankin Scale (mRS)
时间窗: At 3/6/12 months after onset
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
次要结局
- Fatigue(At 12 months after onset)
- Delayed infarction(After onset (max 30 days))
- Delayed ischemia(After onset (max 30 days))
- Self-Rating Anxiety Scale (SAS)(At 3/6/12 months after onset)
- Hamilton Rating Scale for Depression(At 3/6/12 months after onset)
- Non-neurological systemic complications(After onset (max 60 days))
- Hematoma expansion in intracerebral hemorrhage(24-48 hours from symptom onset)
- Montreal Cognitive Assessment Scale (MoCA)(At 3/6/12 months after onset)
- Mortality rate(At 12 months after onset)
- Total time spent on the intensive care unit (ICU)/stroke unit(After treatment (max 60 days))
- Recurrence of intracerebral hemorrhage(90 days from symptom onset)
- Rebleeding of subarachnoid hemorrhage(After onset (max 7 days))
- Mini-mental State Examination (MMSE)(At 3/6/12 months after onset)
- Self-Rating Depression Scale (SDS)(At 3/6/12 months after onset)
- Hamilton Rating Scale for Anxiety(At 3/6/12 months after onset)
研究者
Xiaolin Chen, MD
Principal Investigator
Beijing Tiantan Hospital