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临床试验/NCT02350010
NCT02350010Unknown不适用

The Research of Etiology and Risk Factors Related to Prognosis of Intracerebral Hemorrhage in Beijing

Beijing Neurosurgical Institute1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
试验地点
1
主要终点
one-year functional outcome and mortality of Intracerebral hemorrhage.

研究概览

简要总结

There were lack of data and analysis about medical management, etiology, and long-term outcome of Intracerebral Hemorrhage (ICH) in Beijing. In this study the investigators do acute CT angiography, a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further the investigators will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH.

详细描述

Intracerebral hemorrhage (ICH) accounts for 10 %-15 % of all strokes and is one of leading causes of stroke related mortality and morbidity worldwide. Despite advances in medical knowledge, treatment for ICH remains strictly supportive. ICH accounted for 26.7~51.5% of stroke in China, the proportion was higher than in Western countries. There were lack of data and analysis about medical management, etiology, and long-term outcome of ICH in Beijing.

In this study we do acute CT angiography (CTA), a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further we will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH. There are some studies of CTA to assess the cause of ICH and functional outcomes, but lack of multi-center, large sample studies to support and validate these findings, particularly fewer application of postcontrast CT. This would allow an early intervention base on different causes and Select treatment decisions according to risk score.

We are planning to:

When patients with ICH arrive in stroke department of the topic cooperation hospitals within 72 hours after symptom onset, they will be subject to CTA with the protocoled sequences.

Standard sequences: Pre- and postcontrast head imaging is acquired from the skull base to vertex with parameters: 120 kVp; 340 mA; 4x5 mm collimation; 1second/rotation; and a table speed of 15 mm/rotation. CTA was performed immediately after initial noncontrast CT(NCCT) performance using a bolus-tracking method by injecting 90 mL of nonionic iodinated contrast (OPTIRAY 350) at 5 mL/s. The protocol for the circle of Willis was 120 kVp, 360 mAs, 0.5 second/rotation, 0.75 mm thick with a pitch of 0.65. Postprocessing procedure including multiplanar reconstruction was performed by a CT technologist at the CT operator's discretion for assessment of contrast extravagation and etiologies of ICH such as vascular malformation, and venous sinus thrombosis. Coronal and sagittal multiplanar reconstructed images were created as 10.0-mm-thick images spaced by 3 mm. Axial reformed images were 4 mm thick with 2-mm spacing.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CT demonstrated ICH
  • Age above 18
  • within 72 hours of symptom onset
  • Informed consent from patient or proxy

排除标准

  • allergy to contrast medium incompletion of a standard CT protocol including noncontrast CT (NCCT) and CTA Lack of informed consent

结局指标

主要结局

one-year functional outcome and mortality of Intracerebral hemorrhage.

时间窗: one year

Good functional outcome was defined as modified Rankin Scale score (mRS) ≤2.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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