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临床试验/NCT03801694
NCT03801694已完成不适用

To Evaluate the Role of Plasma Catecholamine Levels in Predicting the Development of Myocardial Depression in Acute Neurological Patients

Ohio State University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年12月3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
4
试验地点
1
主要终点
Association of plasma catecholamine levels with stress induced cardiomyopathy

研究概览

简要总结

The purpose of this study is to assess the levels of serum catecholamines associated with myocardial depression (MD) in patients with acute neurological injury.

详细描述

The purpose of this study is to investigate the level of plasma catecholamines, associated with myocardial depression (MD) as noted on Transthoracic ECHO (TTE) by evidence of wall motion abnormalities (WMA) with or without drop in ejection fraction or symptomatic heart failure (HF). Takotsubo syndrome (TTS) is commonly diagnosed after the onset of HF once patients become symptomatic. The investigators intend to study whether early MD can be detected by identifying certain levels of plasma catecholamines and whether the level correlates with severity of myocardial depression. Identification of early MD changes can lead to alteration of management strategies and may help prevent worsening of HF. Highly selected patients with Subarachnoid Hemorrhage (SAH) or Acute Ischemic Stroke (AIS) requiring induced hypertension with the use of norepinephrine infusion will be recruited to enroll in this pilot study. This group of patients are expected to have high circulating catecholamines and are more likely to develop MD. Given the prevalence of TTS in females and elderly, 10 female patients >50 years admitted to the neuro ICU with diagnosis of either AIS or SAH will be enrolled. Patients with history of coronary artery disease, smoking, poorly controlled diabetes with HbA1c >8 and uncontrolled hypertension will be excluded. Patients with poor ECHO windows will also be excluded. Baseline plasma catecholamine levels, transthoracic ECHO(TTE), Troponin T, EKG and BNP will be obtained and will be followed daily through the study duration.

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
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female patients >50 years admitted to the neuro ICU with diagnosis of either acute ischemic stroke or subarachnoid hemorrhage
  • Only patients predicted to be on norepinephrine infusion for at least 48 hrs will be selected.

排除标准

  • patients with known history of heart failure will be excluded
  • Patients with history of coronary artery disease, smoking, poorly controlled diabetes with HbA1c >8 and uncontrolled hypertension will be excluded.
  • Patients with poor ECHO windows will be excluded

结局指标

主要结局

Association of plasma catecholamine levels with stress induced cardiomyopathy

时间窗: up to 5 days

Baseline plasma catecholamine levels as well as daily levels will be measured until up to 5 days from study onset. Baseline transthoracic ECHO followed by daily ECHO with strain imaging will be obtained to assess for evidence of myocardial depression. The investigators will assess the correlation of plasma catecholamine levels (i.e level of dopamine, epinephrine and norepinephrine) in the development of myocardial depression. In other words, the investigators will evaluate the level of catecholamines that is associated with stress induced cardiomyopathy. If participants develop symptomatic heart failure before 5 days, study will stop at that point.

Association of troponin levels with stress induced cardiomyopathy

时间窗: up to 5 days

Baseline troponin level will be measured as well as daily levels will be obtained for 5 days. The investigators will study the correlation of troponin levels with the myocardial depression noted on ECHO.

次要结局

  • Association of ST-T changes on EKG with stress induced cardiomyopathy(up to 5 days)

研究者

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

Tamara Strohm

Assistant Professor- Neurology

Ohio State University

研究点 (1)

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