跳至主要内容
临床试验/NCT04359940
NCT04359940Unknown不适用

The Effect of Different Contouring Techniques on Cardiac Magnetic Resonance Assessment of Right Ventricular Volumes in Repaired Tetraology of Fallot: Implications on Preoperative Thresholds for Intervention

University Hospital Birmingham NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Difference in the baseline measurement of indexed right ventricular end-diastolic volume according to the contouring technique

研究概览

简要总结

Patients with repaired tetralogy of Fallot (RTOF) develop chronic pulmonary regurgitation and require monitoring for right ventricular dilatation. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. The investigators sought to determine whether the choice of myocardial contouring technique affects preoperative RV volumetric thresholds for intervention.

详细描述

Participants with repaired tetralogy of Fallot (RTOF) will be identified using existing patient electronic records who have developed chronic pulmonary regurgitation and are undergoing monitoring for right ventricular dilatation. Cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. There are different post-processing techniques published for measuring RV volumes on cardiac magnetic resonance imaging (detailed vs. smoothed and manual vs. automated). The primary aim of this study is to identify whether the choice of myocardial contouring technique affects the preoperative RV volumetric thresholds for intervention. As a secondary aim, the investigators will determine the reproducibility of different contouring methods.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients with repaired Tetralogy of Fallot undergoing routine clinical surveillance at a Level 1 ACHD surgical referral centre.

排除标准

  • 未提供

结局指标

主要结局

Difference in the baseline measurement of indexed right ventricular end-diastolic volume according to the contouring technique

时间窗: Cross-sectional study. Repeated measurements performed on the baseline CMR study.

Measurements of indexed right ventricular end-diastolic volume will be repeated using different contouring techniques on the same cardiac MRI study performed at baseline pre-surgery.

次要结局

未报告次要终点

研究者

发起方
University Hospital Birmingham NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

William E Moody

Consultant Cardiologist

University Hospital Birmingham NHS Foundation Trust

研究点 (2)

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