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临床试验/NCT04038879
NCT04038879Unknown不适用

Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation

Atlantic Health System1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Correlation of echocardiography and MRI

研究概览

简要总结

The primary treatment for patients determined to have severe aortic or mitral regurgitation is surgical repair or replacement their valves. The most commonly used tool to quantify the severity mitral and aortic regurgitation is echocardiography. Studies have shown that echocardiography may have significant limitations in quantifying regurgitant volume. MRI has recently been shown to easily and reproducibly quantify regurgitation. To better understand how to accurately quantify severity of regurgitation the investigators propose this study with the following aims: 1) compare MRI to echocardiography in the evaluation of regurgitant volume in patients with aortic or mitral regurgitation and 2) to assess which technique is better at predicting the response of the left ventricle to valve surgery.

详细描述

The primary treatment for patients determined to have severe aortic or mitral regurgitation is surgical repair or replacement their valves. The most commonly used tool to quantify the severity mitral and aortic regurgitation is echocardiography. Studies have shown that echocardiography may have significant limitations in quantifying regurgitant volume. MRI has recently been shown to easily and reproducibly quantify regurgitation. To better understand how to accurately quantify severity of regurgitation the investigators propose this study with the following aims: 1) compare MRI to echocardiography in the evaluation of regurgitant volume in patients with aortic or mitral regurgitation and 2) to assess which technique is better at predicting the response of the left ventricle to valve surgery.

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

入选标准

  • Age ≥18 years of age
  • Able to give informed consent
  • Referred for isolated aortic or mitral valve repair or replacement due to valve regurgitation

排除标准

  • Inability to provide consent.
  • Pregnancy
  • Claustrophobia
  • Metallic contraindications to MRI (e.g. noncompatible aneurysm clip etc)
  • Known intracardiac shunt
  • Planned concomitant cardiac surgical procedure such as coronary artery bypass, septal myomectomy, or other valve procedure.
  • More than mild mitral or aortic stenosis.
  • For patients enrolled with mitral regurgitation: greater than mild aortic regurgitation.
  • For patients enrolled with aortic regurgitation: greater than mild mitral regurgitation.
  • Hypertrophic cardiomyopathy.

结局指标

主要结局

Correlation of echocardiography and MRI

时间窗: 6 month

Correlation of echocardiography and MRI

Change in LV EDV post surgery

时间窗: 6 month

Change in LV EDV post surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seth Uretsky

Medical Director, Cardiovascular Imaging

Atlantic Health System

研究点 (1)

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