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临床试验/NCT03281395
NCT03281395已完成不适用

Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2011年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample (baseline)

研究概览

简要总结

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigator will study the safety of RVP, particularly for the heart and the brain, retrograde by studying troponin levels and magnetic resonance imaging or computed tomography.

详细描述

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood pressure and clinical outcome were used as study parameters. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected if only clinical outcome is taken as a study parameter. In this retrograde study, the investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging or computed tomography and troponin levels. The purpose of this study is to evaluate the effect of repetitive periods of RVP on the oxygenation of the heart and brain using magnetic resonance imaging and troponin levels both markers for ischemia damage.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • 未提供

排除标准

  • cardiac abnormalities
  • coronary heart disease
  • valvular heart disease
  • pregnancy

结局指标

主要结局

Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample (baseline)

时间窗: A first blood sample is collected immediately preoperative in the operating room. Postoperative samples are taken at 24 hours up to 60 hours after start surgery

For detection of myocardial injury, the cardiac specific enzyme Troponin(cTnl)is evaluated pre-and postoperatively

次要结局

  • Magnetic resonance imaging or computed tomography(Preoperative and within 1 week post surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joke De Wachter

data manager

University Hospital, Antwerp

研究点 (1)

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