NCT03726528已完成不适用
Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops
University of Luebeck2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年9月1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
- 25
- 试验地点
- 2
- 主要终点
- Changes in contractility derived from pressure-volume measurements
研究概览
简要总结
Aim of this prospective study is to assess the pathophysiology of Takotsubo Syndrome by obtaining pressure volume loops with conductance catheters, which allows detailed conclusions regarding systolic and diastolic hemondynamics and subsequently regarding potential underlying mechanisms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Takotsubo syndrome according to current diagnostic criteria including complete normalization of left ventricular function during follow-up
- •Sinus rhythm during invasive measurements
- •Age ≥18 years
- •Written informed consent
排除标准
- •Cardiogenic shock
- •Signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging
- •Pregnancy
- •Participation in another trial
结局指标
主要结局
Changes in contractility derived from pressure-volume measurements
时间窗: Day 0
systolic/diastolic pressure-volume relationship (mmHg/ml)
次要结局
- - Correlation of pressure-volume measurements with morphological and functional findings in CMR imaging(Day 3)
- - Correlation of pressure-volume measurements with biomarker release(Day 0)
- Energetic parameters derived from pressure-volume measurements(Day 0)
- Afterload parameters derived from pressure-volume measurements(Day 0)
研究者
Prof. Dr. med. Ingo Eitel
MD, Director
University of Luebeck
研究点 (2)
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