NCT05748041招募中不适用
Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification
IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- 2D-CMR (different methods)
研究概览
简要总结
The aims of this study are:
- to explore a novel 2D-Cardiovascular magnetic resonance (CMR) indirect method for tricuspid regurgitation (TR) quantification (ATRIAL method) relying on right atrium variables, and assess its agreement with the traditional indirect method (involving right ventricle variables) and the direct method (based on through-plane phase contrast (PC) sequences on the tricuspid valve);
- to assess the agreement of TR volume (RVol) and regurgitant fraction quantification from 2D-CMR methods with transthoracic echocardiography and 4DF-CMR methods;
- to assess the diagnostic performance of 2D-CMR in classifying TR, in terms of RVol and regurgitant fraction, with respect to echocardiographic transthoracic echocardiography grades.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged ≥ 18 years with the diagnosis of al least mild-degree tricuspid regurgitation, who:
- •patients that are scheduled for a Cardiovascular Magnetic Resonance examination in our Institution
排除标准
- •Patients with previous surgical or transcatheter interventions on the tricuspid valve
- •Patients with Ebstein's disease
- •Subjects with pace-maker or intracardiac defibrillator
- •Subjects with intrabody ferromagnetic material precluding patient's safety
- •Patients with claustrophobia or breath-holding precluding an adequate CMR images quality
- •Pregnant women
结局指标
主要结局
2D-CMR (different methods)
时间窗: 3 years
次要结局
- RVol and RF(3 years)
研究者
Giulia Pasqualin
Investigator
IRCCS Policlinico S. Donato
研究点 (1)
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