跳至主要内容
临床试验/CTRI/2023/07/055283
CTRI/2023/07/055283已完成不适用

Comparison of left ventricular ejection fraction obtained by 2D mitral E point septal separation and 3D mitralE point septal separation linear and area methods with that of 2D and 3D volumetric methods using transesophageal echocardiography.

Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
2. Correlation of 3D mitral EPSS area with 2DE modified Simpson’s LVEF & 3DE LVEF in patients with

研究概览

简要总结

Estimation of left ventricular ejection (LVEF) fraction is an integral part of assessment of LV systolicfunction and most commonly used to assess LV systolic function, and the reduction of LVEF is seen to be associate with decreased survival rate(4).The gold standard for assessment of LVEF is using Cardiac MR(CMR) . Estimation of LVEF using modified Simpson’s biplane technique is routinely performed during cardiac surgery in the pre and post cardiopulmonary bypass period and is the currently the only recommended method for calculation of LVEF using TEE. Off all the different echo modalities used for assessment of EF, compared to CMR, 3DE currently offers the closest approximation. 3DE uses volumetric approach for acquisition of data , its visualization and quantification. This allows distance between 2 structures to be measured more accurately. Mitral EPSS is largely utilized in the emergency care for quick and reliable assessment of EF. EPSS was initially studied in 1970s as easily measured, quantitative index of LV function with a good reproducibility Elagha A et al. studied Mitral EPSS by CMR and found that EPSS measurement by CMR is reliable and easy to perform and allows parallel assessment of LV function in both normal patients and patients having myocardial fibrosis.Cosansu et al. was able to prove that the ratio of left ventricular internal diameter in diastole(LVIDd) with EPSS or LVIDd/EPSS was able to predict advanced HF and cases with EF<40% more accurately .Area of separation of mitral valve from LV septal wall can be measured on 3DE. 3DE assessment of mitral EPSS and EPSS area has a potential to predict LVEF more accurately and currently remains an unstudied territory.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Male

入选标准

  • •All adults above 18 years of age, in sinus rhythm, admitted with CAD for elective CABG surgery will be included in the study.

排除标准

  • •Emergency surgeries
  • •Redo surgeries
  • •Patients not willing to participate in study
  • •More than mild AR, MR or TR
  • •Patients with Mitral valve pathology causing restricted or increased mobility of leaflets
  • •Patients receiving preoperative inotropes
  • •Patients with poor echo differentiation of endocardial borders
  • •Patient with arrhythmias.
  • •Contraindication to TEE probe placement like esophageal strictures, esophageal varices, esophageal tumors, gastric ulcer, previous esophagectomy, esophageal diverticulum, tracheoesophageal fistula, previous bariatric surgery, hiatus hernia, large descending thoracic aortic aneurysm, unilateral vocal cord paralysis, esophageal varices, post-radiation therapy.

结局指标

主要结局

2. Correlation of 3D mitral EPSS area with 2DE modified Simpson’s LVEF &amp; 3DE LVEF in patients with

时间窗: Pre CPB initiation

EPSS area.

时间窗: Pre CPB initiation

from modified Simpson’s formula in patients with normal LV systolic function (LVEF more than 52% in

时间窗: Pre CPB initiation

men &amp; 54% in women) &amp; their correlation with LVEF obtained by 3DE volumetric assessment as a reference method.

时间窗: Pre CPB initiation

1. Comparison of 2D mitral EPSS-based LVEF &amp; 3D mitral EPSS-based LVEF with 2D LVEF measured

时间窗: Pre CPB initiation

good LV &amp; deranged LV function. We also would try to derive a formula to calculate LVEF using 3D

时间窗: Pre CPB initiation

次要结局

  • 1. Comparison of LVEF obtained by 2D & 3D mitral EPSS, modified Simpson’s formula and their(correlation with LVEF obtained by 3DE volumetric assessment as a reference method.)

研究者

发起方
Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum
申办方类型
Research institution and hospital

研究点 (1)

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