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临床试验/CTRI/2018/01/011089
CTRI/2018/01/011089已完成不适用

Mitral Annular Plane Systolic Excursion/Left ventricular length (MAPSE/L) – A novel index for assessing left ventricular longitudinal function in pediatric tetrology of fallot patients undergoing surgical repair.

Postgraduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
To assess the correlation of Mitral Annular Plane Systolic Excursion/Left Ventricular Length with Left Ventricle Ejection Fraction in pediatric tetrology of fallot patients undergoing cardiac surgery for total intracardiac repair.

研究概览

简要总结

This is a prospective observational study to assess the left ventricle longitudinal function by using a novel index (MAPSE/L). The primary outcome of this study will be assessing the correlation of Mitral Annular Plane Systolic Excursion/ Left Ventricle Length (MAPSE/L)  with Left Ventricle Ejection Fraction in pediatric Tetrology of Fallot patients undergoing surgery for total intracardiac repair. This study will be conducted in Advanced Cardiac Center, PGIMER, chandigarh. The secondary outcomes of this study will be assessing the relationship of MAPSE/L with other echocardiographic parameters such as Left ventricle Global Longitudinal Strain, Right ventricle Global Longitudinal Strain, Tricuspid Annular Plane Systolic Excursion, Right Ventricle Fractional area Change and Left ventricle diastolic function indices. Also, in this study,  prediction of low cardiac output syndrome, left ventricle dysfunction, prolonged mechanical ventilation and prolonged ICU stay after total intracardiac repair of Tetrology of Fallot by using MAPSE/L.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Pediatric patients with tetrology of fallot physiology posted for total intracardiac repair under cardiopulmonary bypass will be included in this study.

排除标准

  • Patients with perforated viscus, esophageal stricture, esophageal diverticulum, esophageal injury, tracheoesophageal fistula, previous upper Gastrointestinal surgery, coagulopathy and thrombocytopenia are contraindicated for transesophageal echocardiography will be excluded.
  • Patients with absent pulmonary valve syndrome will be excluded.
  • Patients not willing to participate in the study will be excluded.

结局指标

主要结局

To assess the correlation of Mitral Annular Plane Systolic Excursion/Left Ventricular Length with Left Ventricle Ejection Fraction in pediatric tetrology of fallot patients undergoing cardiac surgery for total intracardiac repair.

时间窗: 1)TTE on table before induction of anaesthesia | 2)TTE on table after induction of anaesthesia | 3)TEE on table before CPB | 4)TEE on table after CPB | 5)TTE in ICU in Post Operative Day (POD) 1 | 6)TTE at the time of discharge from ICU | 7)TTE at 3 month follow up

次要结局

  • To assess the relationship of MAPSE/L with other echocardiography parameters such as Left Ventricle Global Longitudinal Strain by speckle tracking method, Right Ventricle Global Longitudinal Strain, Right Ventricle Fractional Area Change, Tricuspid Annular Plane Systolic Excursion, and Left Ventricle Diastolic function indices.(1)TTE on table before induction of anaesthesia)
  • To use MAPSE/L in prediction of early surgical outcomes like Left Ventricle dysfunction, low cardiac output syndrome, mechanical ventilation, Intensive care unit stay(Immediate postoperative period and at 3 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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