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临床试验/NCT07151495
NCT07151495尚未招募不适用

The Additive Prognostic Value of Speckle Tracking Echocardiography Compared to Bernard's Staging in Patients Undergoing Mitral Valve Surgery

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 300 人开始时间: 2025年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
主要终点
All cause or cardiovascular mortality

研究概览

简要总结

Mitral valve prolapse is the most common cause of mitral regurgitation requiring surgery in developed countries. While cardiac surgery is recommended for symptomatic patients, in accordance with the ESC guidelines on valvular heart disease, indications for intervention in asymptomatic patients are mainly based on two-dimensional echocardiographic criteria: the presence of left ventricular systolic dysfunction or dilatation (end-systolic diameter ≥ 40 mm and/or ejection fraction ≤ 60%); or, in patients with preserved left ventricular systolic function, the occurrence of atrial fibrillation secondary to valvular disease or pulmonary hypertension (systolic pulmonary artery pressure > 50 mmHg); finally, significant left atrial dilatation (indexed left atrial volume ≥ 60 ml/m² or diameter ≥ 55 mm) also represents an indication. Mitral valve repair is preferred over valve replacement with a prosthesis, as it is associated with lower intraoperative mortality, better long-term survival, and fewer valve-related complications. However, the cut-off values derived from conventional echocardiography and used as indicators for surgical intervention may reflect an already severe and irreversible structural and functional cardiac alteration. Moreover, they do not consider more advanced imaging techniques such as speckle tracking echocardiography, which is now widely used in clinical practice and allows for a quantitative assessment of myocardial function through the analysis of myocardial fiber shortening in the cardiac walls. Several studies have shown that preoperative peak left atrial longitudinal strain (PALS) has prognostic value in predicting postoperative clinical outcomes in patients undergoing surgery for primary mitral regurgitation, as well as in predicting left atrial reverse remodeling; this prognostic relevance has also been observed in asymptomatic patients and in cases of less than severe mitral regurgitation. Furthermore, Bernard et al. demonstrated the prognostic value of a staging system for extra-valvular cardiac damage, assessed using two-dimensional echocardiographic data, in asymptomatic patients with moderate or severe mitral regurgitation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with severe primary mitral regurgitation treated with cardiac surgery
  • Age > 18 years
  • Signed informed consent form/Substitute declaration in place of the signed informed consent form in the case of deceased patients

排除标准

  • Known coronary artery disease
  • Infective endocarditis
  • Functional mitral regurgitation
  • Presence of additional left-sided valvular heart disease greater than mild
  • History of prior cardiac surgery
  • History of rheumatic valvular disease
  • Pregnancy
  • Absence of a signed informed consent form/Absence of the signed substitute declaration in the case of deceased patients

结局指标

主要结局

All cause or cardiovascular mortality

时间窗: 3 months

To determine the additive prognostic value for the primary outcome (all cause or cardiovascular mortality) of left atrial speckle-tracking echocardiography (PALS) over Bernard's staging

次要结局

  • Composite endpoint: all cause or cardiovascular mortality, new onset of atrial fibrillation, hospitalization for cardiovascular cause (heart failure, acute coronary syndrome)(3 months)

研究者

申办方类型
Other
责任方
Sponsor

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