跳至主要内容
临床试验/CTRI/2024/11/077159
CTRI/2024/11/077159招募中不适用

Validation of Intraoperative 3D Transesophageal Echocardiography Derived Ventricular Volumes and Ejection Fraction in Adults with Cardiac MRI: Prospective Non-Randomized Interventional Study

Dr Haasith Dara1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2024年12月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
17
试验地点
1
主要终点
To assess the correlation of 3-dimensional Transesophageal Echocardiography (TEE) -derived LV volumes, EF and mass; and RV volumes and EF with Cardiac MRI (CMR).

研究概览

简要总结

Accurate intraoperative assessment of cardiac function is crucial for optimizing perioperative management in cardiac surgery. Left ventricular (LV) volumes and ejection fraction (EF) are essential for evaluating myocardial contractility, while right ventricular (RV) assessment is important for understanding pulmonary circulation dynamics. Transesophageal echocardiography (TEE) is the standard imaging tool used in these settings, but traditional two-dimensional (2D) TEE has limitations, including geometric assumptions and suboptimal resolution, leading to variability in measurements. 3-dimensional TEE is superior to 2D TEE as it does not have any limitations of geometric assumptions. However, until now, 3D TEE has not been validated with the gold standard cardiac MRI. This trial aims to validate the measurements obtained from intraoperative 3D TEE with cardiac magnetic resonance imaging (CMR), for assessing ventricular volumes and EF. The goal of this study is to establish the accuracy and reliability of 3D TEE measurements in the intraoperative context.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adult patients posted electively for CABG, valve replacements/repair or ASD closure with optimal images for transthoracic and transesophageal echocardiography.

排除标准

  • Patients with arrhythmia.
  • Contra-indication to TEE probe placement.
  • Patients undergoing emergency surgery.
  • Patients undergoing re-do surgeries.
  • Patients with change in symptomatology between cardiac magnetic resonance imaging and surgery.

结局指标

主要结局

To assess the correlation of 3-dimensional Transesophageal Echocardiography (TEE) -derived LV volumes, EF and mass; and RV volumes and EF with Cardiac MRI (CMR).

时间窗: Baseline | Intraoperative

次要结局

  • To assess the correlation of 3D TEE-derived LV volumes, EF & mass; & RV volumes & EF with 3D TTE.(Intraoperative)
  • To assess the intra-class correlation of 3D TEE at the following time points.

研究者

发起方
Dr Haasith Dara
申办方类型
Other [individual]
责任方
Principal Investigator
主要研究者

Dr Sathya Narayan R

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

Loading locations...

相似试验

Advanced heart Imaging during cardiac surgery | 临床试验