跳至主要内容
临床试验/CTRI/2024/05/067580
CTRI/2024/05/067580尚未招募不适用

Coronary Sinus diameter as a predictor of Right Ventricular dysfunction in patients undergoing Mitral Valve surgery

UN Mehta Institute of Cardiology and Research Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To explore the correlation between coronary sinus diameter and right ventricular dysfunction at different intervals in the postoperative period in patients who have undergone mitral valve surgery, as well as its relationship to right ventricular myocardial performance index.

研究概览

简要总结

TITLE:   CORONARY SINUS DIAMETER AS A PREDICTOR OF RIGHT VENTRICULAR DYSFUNCTION IN PATIENTS UNDERGOING MITRAL VALVE SURGERY 

The RV function of patients going through Mitral valve surgery is affected in the early stages, and through a range of pathways. Furthermore, the application of cardiopulmonary bypass and pericardiotomy in surgical interventions weakens the natural RV contraction pattern and may lead to further impairment. RV dysfunction is a major clinical problem in the postoperative setting due to the substantial morbidity and mortality it can cause.

Intraoperatively, RV function can be judged by Echo parameters such as Tricuspid Annular Plane Systolic Excursion (TAPSE), RV Fractional Area Change (FAC), and RV Myocardial Performance Index (MPI), although they are intricate and have their own constraints.

Recent literature indicated that Coronary sinus diameter may be indicative of RV impairment in those with heart failure and in the pediatric cardiac surgery population. There is a paucity of literature available in forecasting RV dysfunction in individuals undergoing valve replacement.

AIM AND OBJECTIVES:

The main purpose of the study is to explore the correlation between coronary sinus diameter and right ventricular dysfunction at different intervals in the postoperative period in patients who have undergone mitral valve surgery, as well as its relationship to right ventricular myocardial performance index.

Investigating the association between VIS score (VIS max), mechanical ventilation duration, ICU stay, hospital stay, and mortality is the secondary objective.

STUDY DESIGN:

It will be a prospective observational study over 1 year duration.

One hundred consenting patients going through Mitral valve surgery will be monitored for Coronary Sinus diameters at multiple points like preoperatively, after induction, just before being moved to the recovery ICU and in the postoperative period.

RVMPI ,IVC and LVEF will be measured  at same time points.

VIS Score will be calculated at various time points in the  postoperative period and VIS max will be noted, Mechanical ventilator stay, length of ICU stay, length of Hospital stay and Mortality.

INCLUSION CRITERIA :

Age18 – 65 years

Sex- both

Patients undergoing elective Mitral valve replacement without TR or Mild to moderate TR

EXCLUSION CRITERIA :

Patients With persistent left superior vena cava, total anomalous pulmonary venous return, coronary atrioventricular fistula, anomalous hepatic venous drainage, coronary sinus thrombosis and any  postoperative  coronary sinus obstruction.

Patients With Severe TR or eccentric TR jet towards Coronary Sinus

Patients requiring concomitant  Aortic valve surgery or CABG

Patients With severe LV Dysfunction.

Patients in whom TEE is contraindicated.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective Mitral valve replacement without Tricuspid regurgitation or Mild to moderate Tricuspid regurgitation.

排除标准

  • Patients With persistent left superior vena cava, total anomalous pulmonary venous return, coronary atrioventricular fistula, anomalous hepatic venous drainage, coronary sinus thrombosis and any postoperative coronary sinus obstruction.
  • Patients With Severe Tricuspid regurgitation or eccentric Tricuspid regurgitation jet towards Coronary Sinus Patients requiring concomitant Aortic valve surgery or Coronary artery bypass graft Patients With severe Left ventricular Dysfunction.
  • Patients in whom Trans esophageal echocardiography is contraindicated.

结局指标

主要结局

To explore the correlation between coronary sinus diameter and right ventricular dysfunction at different intervals in the postoperative period in patients who have undergone mitral valve surgery, as well as its relationship to right ventricular myocardial performance index.

时间窗: Coronary sinus diameter is measured pre operatively and post operatively 24 hours after shifting to ICU

次要结局

  • Investigating the association between Vasoactive inotrope score score (VIS max), mechanical ventilation duration, ICU stay, hospital stay, & mortality is the secondary objective.

研究者

发起方
UN Mehta Institute of Cardiology and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Ram Kiran KS

UN Mehta Institute of Cardiology and Research Centre

研究点 (1)

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