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临床试验/NCT05006443
NCT05006443已完成不适用

Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年1月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
75
试验地点
1
主要终点
Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging

研究概览

简要总结

The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).

详细描述

40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities as shown in the flow diagram below. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Moderate or more tricuspid regurgitation

排除标准

  • •Prior tricuspid valve prosthesis
  • •Pacemaker/defibrillator that would impede MRI imaging
  • •Planned tricuspid valve surgery
  • •Primary liver pathology

研究组 & 干预措施

Moderate or severe tricuspid regurgitation

Other

40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

干预措施: Cardiac Magnetic Resonance (Diagnostic Test)

结局指标

主要结局

Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging

时间窗: 1 year

Incidence of severity of TR by CMR as compared with current gold standard (TTE)

次要结局

  • Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography(1 year)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamad Adnan Alkhouli

Professor of Medicine

Mayo Clinic

研究点 (1)

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