跳至主要内容
临床试验/NCT01585311
NCT01585311终止不适用

Impact of Prolonged Tachycardia on Cardiovascular Morbidity and Outcome After Subarachnoid Hemorrhage (SAH)

Columbia University1 个研究点 分布在 1 个国家目标入组 1,540 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1,540
试验地点
1
主要终点
modified Rankin Scale (mRS) score

研究概览

简要总结

The purpose of this retrospective study is to test the hypothesis that uncontrolled tachycardia serves as a risk factor for adverse cardiovascular events and poor outcome after Subarachnoid Hemorrhage (SAH).

详细描述

The design of the current study will be to conduct a retrospective analysis of prolonged heart rate and uncontrolled tachycardia using patients enrolled in the investigators prospective observational cohort study since the electronic medical record systems have been implemented. The investigators know that there have been periods when these electronic systems have failed, resulting in lost data. The investigators anticipate retrospective collection of hourly heart rate for approximately 400 SAH patients that will have ICU data and 3 month modified Rankin documented in our Subarachnoid Hemorrhage Outcomes Project (SHOP) database. The investigators will determine what percent of them have prolonged elevated heart rate and tachycardia. Prolonged heart rate and uncontrolled tachycardia has been defined as a heart rate greater than 95 for greater than 12 hours in one 24 hour period of their ICU stay. The investigators will conduct a ROC curve analysis to determine the appropriate heart rate and duration thresholds that are most predictive of poor prognosis after SAH. Patients be will stratified based on several criteria including admission coma score, early (SAH day 0 to 3) or late (SAH day >=4) ICU admission, presence of intraventricular hemorrhage on admission CT, history of beta-blocker usage, age, and gender.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Age >=18 years
  • Diagnosis of subarachnoid hemorrhage established by computed tomography (CT scan) or xanthochromia of the cerebrospinal fluid if the CT is negative
  • Written informed consent from either the patient or a family member
  • Admitted to the NICU for at least 12 hours

排除标准

  • Age < 18yrs
  • traumatic SAH
  • SAH due to a rupture of an arteriovenous malformation, neoplasm vasculitis or other secondary causes

结局指标

主要结局

modified Rankin Scale (mRS) score

时间窗: Three months

次要结局

  • Prevalence of Major Adverse Cardiovascular Events (MACE)(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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