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临床试验/NCT03761654
NCT03761654已完成不适用

Detection of Myocardial Dysfunction in Non-severe Subarachnoid Hemorrhage (WFNS 1-2) Using Speckle-tracking Echocardiography (STRAIN)

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2019年1月2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
117
试验地点
1
主要终点
Global Longitudinal Strain

研究概览

简要总结

Subarachnoid hemorrhage (SAH) can cause transient myocardial dysfunction. Recently, it have been reported that myocardial dysfunctions that occur in SAH are associated with poor outcomes. It therefore appears essential to detect theses dysfunctions with the higher sensitivity as possible. Strain measurement using speckle-tracking echocardiography may detect myocardial dysfunction with great sensitivity. The main objective of this study is to assess the prevalence of myocardial dysfunction in "non-severe" SAH (defined by a WFNS grade 1 or 2), using speckle-tracking echocardiography. This study also aims to analyse Strain measurement with classical echocardiography and serum markers (troponin, BNP) of cardiac dysfunction.

详细描述

Cardiac complication, occurring in the early phase of SAH has been well described. It seems that the pathophysiological mechanism involves vegetative hyperactivity due to the acute cerebral injury. It has been shown that stress cardiomyopathy is associated with delayed cerebral ischemia (DCI) and poor outcomes. Manifestations of stress cardiomyopathy are changes in electrocardiogram, release of cardiac biomarkers such as troponin and BNP, and echography evidence of impaired left ventricle ejection fraction with the use of Simpson technique and regional wall motion abnormalities. These two techniques bear intra-observer variability. A new method is available to assess left ventricular contractility at the bedside. Two-dimensional speckle-tracking images with echocardiography allows one to track a natural myocardial marker within the myocardium by standard transthoracic echocardiography. It provides unique insights into myocardial function such as tissue deformations and strain rate, which is the rate of deformation. This method is more sensitive than classical echographic left ventricular ejection fraction evaluation and bears very low interobserver variability. The Global Longitudinal Strain (GLS) is the most studied parameter.

Early detection of cardiac dysfunction in SAH followed by appropriate monitoring and management may improve outcome in SAH. This is a prospective, observational and mono-center study.

Patients with "non-severe" SAH will benefit from an echocardiography where Left Ventricular Ejection Fraction (LVEF) and GLS will be assessed on day 1, 3 and 7 following the acute injury.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • patient older than 18 years
  • hospitalized in neuro-intensive care unit with a "non-severe" subarachnoid hemorrhage (WFNS 1 or 2)

排除标准

  • low echogenicity
  • history of cardiac malformation or cardiac surgery
  • severe valvular heart disease
  • dilated cardiomyopathy
  • acute coronary syndrome
  • permanent arrythmia
  • patient refusal

结局指标

主要结局

Global Longitudinal Strain

时间窗: Day 1 of hospitalization

It is calculated using values of longitudinal strain measured in the three-,four-, and two-chamber of the left ventricle of the heart. GLS is expressed as percentage. Strain is a measure of myocardial muscle fiber shortening during contraction and is calculated as the systolic segment shortening between end-systolic (ES) segment length (L) and end-diastolic (ED) length: strain = (-LES - LED)/LED x 100 %.

次要结局

  • Change in serum troponin level(Days 1, 3 and 7 of hospitalization)
  • Change in brain natriuretic peptide (BNP) level(Days 1, 3 and 7 of hospitalization)
  • Electrocardiogram abnormalities(Up to day 7 of hospitalization)
  • Global Longitudinal Strain(Day 7 of hospitalization)
  • Change of Left Ventricular Ejection Fraction using Simpson technique(Days 1, 3 and 7 of hospitalization)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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