Validation Study of Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography (MKCG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- HK reproducibility validation
研究概览
简要总结
This study aims to validate the possibility to track cardiac contractility changes with a new technology called 'Heart Kinetic' (HK). HK measurements will be realized and compared echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult between 18 and 50 years old.
- •Healthy without medical cardiac conditions history.
- •Non smoker.
- •Does not take any drugs or medications.
- •Does not participate in other clinical study or trial.
- •BMI (Body Mass Index) in between 20 and 25 kg/m2.
排除标准
- •Being younger than 18 or older than 50 years old.
- •Having had previous cardiac conditions or present disease.
- •Being a regular smoker.
- •Taking any drugs or medications
- •Taking part in another clinical study or trial.
- •BMI (Body Mass Index) lower than 20 or higher than 25 kg/m2.
研究组 & 干预措施
repeatability measures
In this arm, healthy subjects will undergo repeated measures at different times of the day.
干预措施: Cardiac assessment repeatability with Kino-cardiograph (Device)
Contractility changes measures
In this arm, healthy subjects will have their cardiac contractility increased in a controlled way and assessed with both HK and echocardiography.
干预措施: Cardiac contractility assessments with Kino-cardiograph (Device)
结局指标
主要结局
HK reproducibility validation
时间窗: day 1
Validate the reproducibility of HK measurements in a clinical environment.
Cardiac contractility tracking with HK
时间窗: day 1
Proof that the HK technology can track physiological cardiac changes while comparing with gold standard echocardiography and inducing a cardiac contractility change with dobutamine infusion.
次要结局
未报告次要终点
研究者
Philippe Van de Borne
Professor
Erasme University Hospital