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临床试验/NCT07526701
NCT07526701已完成不适用

Clinical Application of Low-Field Magnetic Resonance Imaging in Patients on Extracorporeal Cardiopulmonary Resuscitation

Capital Medical University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Feasibility of 0.23-T MRI examination

研究概览

简要总结

Timely identification of acute brain injury (ABI) patterns in patients with extracorporeal cardiopulmonary resuscitation (ECPR) is essential for prognostic assessment and optimization of clinical management, particularly anticoagulation strategies. This study aimed to evaluate the safety and feasibility of early 0.23-T MRI examination in ECPR patients. The investigators further assessed the image quality of the 0.23-T MRI and investigated the incidence and patterns of ABI, as well as their associations with neurological outcomes. This prospective observational study was conducted in the emergency intensive care unit (EICU) of Beijing Chaoyang Hospital, a high-volume ECPR center. The primary outcome was the feasibility of performing 0.23-T MRI in patients undergoing ECPR, defined as successful completion of the examination without serious adverse events (AEs).

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled patients were those with out-of-hospital cardiac arrest of presumed cardiac cause, supported by ECPR, who achieved ROSC but remained unconscious and unable to obey verbal commands.

排除标准

  • age < 18 years
  • unwitnessed cardiac arrest
  • pregnancy
  • contraindications to MRI (except ECPR, for which safety with 0.23-T MRI has been proved)
  • physical dimensions exceeding scanner limits
  • refusal of consent by the family

研究组 & 干预措施

Enrolled patients were those with out-of-hospital cardiac arrest of presumed cardiac cause

结局指标

主要结局

Feasibility of 0.23-T MRI examination

时间窗: From the initiation of the MRI scan until 6 hours after its completion.

Defined as the percentage of participants who successfully complete the MRI examination without experiencing serious adverse events (AEs). AEs include a decrease in ECMO flow \> 10%, a change in mean arterial pressure of ± 20%, or a change in minute ventilation \> 20%.

次要结局

  • Image Quality(Within 6 hours after the completion of the MRI scan.)
  • Incidence of Acute Brain Injury (ABI)(From the onset of cardiac arrest to the completion of the MRI scan)
  • The association between ABI and neurological outcomes(3 months after ROSC.)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tang Ziren

professor

Capital Medical University

研究点 (1)

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