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临床试验/NCT01670838
NCT01670838已完成不适用

Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients

Kuopio University Hospital3 个研究点 分布在 2 个国家目标入组 198 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
198
试验地点
3
主要终点
Incidence of cardiac failure and the impact of cardiac problems on morbidity

研究概览

简要总结

This is a prospective cohort study investigating cardiac function and cardiac biomarkers in patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to document the incidence of myocardial dysfunction,to find the predictive factors of myocardial dysfunction, describe heart rate variability and to assess the impact of all cardiac problems on morbidity and mortality.

详细描述

Laboratory markers daily: Routine laboratory test (blood gases, haemoglobin, thrombocytes, leukocytes, INR, bilirubin, creatinine, c-reactive protein, CK, CK-MB, Tnt, BNP, sodium, potassium, magnesium) are taken at 8 a.m. Study laboratory tests (sensitive ischemia markers, remodelling marker MMP-9 and CgA as surrogate marker for increased sympathetic activity) are taken four times during study period at the same time as cardiac ECHOes and Holtering. Gene sample is taken once on day one.

Primary outcome measurement is to document the incidence of myocardial dysfunction and the predictive factors during the hospital stay and at three months.

Secondary outcome is to assess the impact of cardiac problems on morbidity and mortality during first three months.

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

  • Patients with nontraumatic subarachnoid haemorrhage
  • Age > 18 years
  • Aneurysmal bleeding

排除标准

  • No consent
  • Age < 18 years
  • Anticipated brain death < 24 hours
  • Otherwise moribund patient

结局指标

主要结局

Incidence of cardiac failure and the impact of cardiac problems on morbidity

时间窗: 6 months

The aims of the study are: 1. to document the incidence of myocardial dysfunction 2. to find the predictive factors of myocardial dysfunction as determined by the severity aneurysmal bleeding (Hunt and Hess-grading, Glasgow coma score, Fisher scale) and demographic factors 3. to find predictive factors for myocardial dysfunction as determined by laboratory findings, electrocardiography, and echocardiography 4. to describe heart rate variability 5. to assess the impact of all cardiac problems on morbidity

次要结局

未报告次要终点

研究者

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

Maarit Lang

MD

Kuopio University Hospital

研究点 (3)

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