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临床试验/NCT01171040
NCT01171040Unknown不适用

Studies on Assessment of Left Atrial Distensibility to Predict Late Prognosis in Consecutive Patients Received Echocardiographic Examination

Kaohsiung Veterans General Hospital.1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
All cause mortality

研究概览

简要总结

Left ventricular filling pressure (LVFP) has prognostic significance in patients with heart failure. Traditionally, it should be assessed by invasive method, as cardiac catheterization and Swan-Gung catheter. In advance of new techniques and modality, echocardiography provides some useful parameters for assessing LVFP, such myocardial tissue Doppler imaging. Many articles had documented that peak velocity of early-diastolic trans-mitral inflow velocity divided by early-diastolic velocity over mitral annulus correlated closely to LVFP. However, myocardial tissue Doppler only provides the information of regional myocardium, so patients with regional wall motion abnormality, as coronary artery disease, can't be assessed by this method without handicap. In addition, conduction disturbance, like bundle branch block, also influences the result of myocardial tissue Doppler. For resolving those problems, the investigators had designed a new global parameter to assess LVFP. In the investigators prior study, left atrial distensibility correlated logarithmically to LVFP in patients with severe mitral regurgitation and also in patients with acute myocardial infarction. Left atrial distensibility provided a new viewpoint to assess left ventricular diastolic function and to predict prognosis. This time, to extend left atrial distensibility to general population received echocardiographic examination for predicting prognosis is attempted.

详细描述

Introduction High left ventricular filling pressure (LVFP) have been associated with volume overload in patients with heart failure and have also been correlated to some extent with more severe symptoms and lower survival rates. In a study of more than 1000 patients hospitalized with acute decompensated heart failure, those with persistently elevated LVFP more than 18 mmHg had increased 1-year mortality compared with those with LVFP less than 16 mmHg. Investigators have also demonstrated that acute reduction of LVFP with vasodilator therapy can improve cardiac function and reduce mortality risk, suggesting that LVFP is an appropriate marker of cardiac risk and functional improvement. However, LVFP measurement involves invasive catheterization, limiting its clinical use especially in the outpatient setting. In advance of new techniques and modality, echocardiography provides some useful parameters to assess LVFP, such myocardial tissue Doppler imaging. Many articles had documented that peak velocity of early-diastolic trans-mitral inflow velocity divided by early-diastolic velocity over mitral annulus was closed correlated with LVFP. However, myocardial tissue Doppler only provides the information of regional myocardium, so patients with regional wall motion abnormality, such as coronary artery disease, can't be assessed by this method without handicap. In addition, conduction disturbance, like bundle branch block, also influences the result of myocardial tissue Doppler. For resolving those problems, we will design a new global parameter to assess LVFP. In prior study, we disclosed the logarithmic relationship between LVFP and left atrial distensibility in acute myocardial infarction patient received primary coronary intervention. This time, to extend our conclusion to general population received echocardiographic examination is attempted. Additionally, we infer that left atrial distensibility which indicates LVFP would influence long-term prognosis, including the event rate of cardiovascular event, stroke and death.

Purpose Left atrial size, particularly left atrial volume, has been recognized as a marker of left ventricular diastolic dysfunction. Contrary to flow and tissue Doppler parameters, left atrial volume is independent of acute volume load and therefore may provide a more accurate assessment of acute and chronic left ventricular dysfunction. In addition, the measurement of left atrial volume is lack of some handicaps of tissue Doppler, including regional myocardial dysfunction in coronary artery disease and bundle branch block. In recent studies, end-systolic left atrial volume (maximal left atrial volume) was useful to predict the risk of atrial fibrillation after cardiac surgery. The short-term and long-term prognosis of acute myocardial infarction was also associated with left atrial volume. In patients with mitral regurgitation, it could be used to reliably estimate the regurgitant volume. Despite end-systolic left atrial volume provides prognostic significance in many disease entities, left atrium is filling and empty in dynamic cyclic motion, so we speculate that left atrial distensibility, defined as the percentage change of left atrial volume between end-systolic and end-diastolic phase, has more prognostic power to represent LVFP and to predict the prognosis. Based on the phenomenon of that higher LVFP, which will conduct to and stretch left atrium in diastolic phase, induces left atrial distension and makes the reduction of distensibility between end-systolic and end-diastolic phases, we had proved the logarithmic relationship between left atrial distensibility and LVFP.

Materials and Methods

Subjects:

2000 consecutive patients received echocardiographic examinations will be enrolled. The exclusion criteria are including (1) patients with prosthetic mitral valves or mitral stenosis, (2) rhythm other than sinus rhythm, (3) age more than 18 years-old, (4) inadequate image quality, (5) lack of informed consent.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • consecutive patients received echocardiographic examination are willing to participate in this study.

排除标准

  • (1) patients with prosthetic mitral valves, or mitral stenosis
  • (2) rhythm other than sinus rhythm
  • (3) age less than 18 years-old
  • (4) inadequate image quality
  • (5) lack of informed consent

结局指标

主要结局

All cause mortality

时间窗: 2 years

All cause mortality and heart failure with re-hospitalization were defined as hard cardiovascular event.

Heart failure with hospitalization

时间窗: 2 years

Heart failure with re-hospitalization is documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needs an augmented decongestive regimen with oral or intravenous medications during an in-hospital stay.

次要结局

  • Atrial fibrillation(2 years)
  • Stroke(2 years)

研究者

申办方类型
Other

研究点 (1)

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