ASSESSMENT OF TEMPORAL CHANGES IN MYOCARDIAL DEFORMATION ANALYSIS AND QUALITY OF LIFE AMONG PATIENTS UNDERGOING VALVE REPLACEMENT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- •Myocardial deformation parameters: Global longitudinal strain (%), 3D auto RV function, 3D chamber volumes
研究概览
简要总结
1. Application of deformation analysis in single and combined valve lesions may provide better insights into attributable factors and help predict functional class and Quality of Life. Integrating deformation analysis aids in identifying subclinical myocardial dysfunction that determines the clinical outcome after valve replacement. Since RV dysfunction is commonly observed in valvular heart disease, additional assessment of RV function before valve intervention may contribute intended surgical approach. Hence, preservation of right heart geometry and its function can impact long-term outcomes in patients undergoing valve replacement.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged above 18 year identified with isolated, severe native valve stenosis/regurgitation with or without concomitant moderate stenosis/regurgitant lesion with or without symptoms, preserved or reduced LVEF (LVEF more or less than 50%) planned for valve replacement as per ACC/AHA 2020 guidelines.
排除标准
- •1.Patients with sub valvar / supravalvular lesions 2.Patients with valve prosthesis undergoing re-do surgery.
- •3.Patients implanted with permanent pacemaker.
- •4.Co-existing pulmonary artery disease of non-cardiac origin.
- •5.Patients diagnosed with coronary artery disease and concomitant valve disease scheduled for bypass surgery and valve replacement.
结局指标
主要结局
•Myocardial deformation parameters: Global longitudinal strain (%), 3D auto RV function, 3D chamber volumes
时间窗: 3 time points | At baseline, pre discharge and 6 month follow up
•Quality of life (WHO BREF score)
时间窗: 3 time points | At baseline, pre discharge and 6 month follow up
Functional Activity assessment (DASI score)
时间窗: 3 time points | At baseline, pre discharge and 6 month follow up
次要结局
- MACE(Non Cardiovascular Mortality)
研究者
Chaithra Nayak
Department of Cardiology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Karnataka, Manipal, 576104, India