跳至主要内容
临床试验/NCT04933188
NCT04933188招募中不适用

Early Detection of Myocardial Work Impairment in Patients With Overweight and Obesity (EARLY-MYO-OBESITY-II)

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
investigate the change of global work efficiency (GWE) in overweight or obese patients

研究概览

简要总结

This prospective study intends to explore the change of cardiac structure and function in the cohort of overweight or obesity patients, and determine the impact of clinical characteristics on cardiac remodeling and mechanics.

详细描述

Obesity significantly increases the risk for heart failure. Early detection of preclinical cardiac dysfunction in overweight or obesity and understanding its association with insulin resistance are of great importance.Recently, a novel technique for myocardial work (MW) assessment has been introduced to evaluate myocardial performance. To date, change of MW has been described in several cardiac conditions including dilated cardiomyopathy, significant coronary arterial diseases, and hypertrophic cardiomyopathy, which implies regional or global myocardial dysfunction. In this study, we aimed to explore the alteration of MW in overweight or obese adults and to determine whether insulin resistance or other clinical risk factors may impact myocardial mechanics before impairment of systolic function.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients were older than 18 without any cardiac symptoms.
  • The diagnosis of overweight was established when body mass index (BMI) of 25 to 30 kg/m
  • Obese was defined as a BMI of 30 kg/m2 or higher.

排除标准

  • diagnosis of type 2-Diabetes Mellitus according to the American Diabetes Association criteria;
  • left ventricular ejection fraction<50% on echocardiography;
  • arrythmia on electrocardiogram;
  • severe valvular stenosis or regurgitation;
  • history of coronary disease (defined as stenosis>50%) or myocardial infarction;
  • stress induced wall motion abnormality on echocardiography, coronary artery stenosis >50% on coronary CT or angiography with Framingham risk score of >10;
  • pacemaker or defibrillator implantation;
  • the presence of bundle branch block;
  • severe infection or renal dysfunction with an estimated glomerular filtration rate < 60 ml/min/1.73 m2);
  • inadequate image quality on echocardiography.

结局指标

主要结局

investigate the change of global work efficiency (GWE) in overweight or obese patients

时间窗: within 24 hours of the recruitment

GWE will be assessed in overweight or obese patients and compare with lean controls

investigate the change of global myocardial work index (GWI) in overweight or obese patients

时间窗: within 24 hours of the recruitment

GWI derived from echocardiography will be assessed in overweight or obese patients and compare with lean controls

investigate the change of global constructive work (GCW) in overweight or obese patients

时间窗: within 24 hours of the recruitment

GCW will be assessed in overweight or obese patients and compare with lean controls

investigate the change of global waste work (GWW) in overweight or obese patients

时间窗: within 24 hours of the recruitment

GWW will be assessed in overweight or obese patients and compare with lean controls

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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