Metabolomic Study of Patients With Cardiomyopathy in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Result of echocardiography
研究概览
简要总结
This study aims to 1)characterize the differentially expressed metabolites between cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated with outcomes or risk evaluation in patients with different cardiomyopathies in a follow-up of a cohort and 3)to determine whether differentially expressed may affect the pathological process of cardiomyopathies . Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of blood plasma.
详细描述
The aim of this study is to analyze metabolomic profile of patients with cardiomyopathy in order to identify biochemical markers with risk stratification and prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors，clinical lab data and previous cardiovascular disease will be recorded. Follow up will be at 3 months,6 months,9 months,1 year and 3 years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients with cardiomyopathy are taken when they enrolled. Serum samples will be analyzed by Liquid Chromatograph Mass Spectrometer/Mass Spectrometer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
- •Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures
排除标准
- •Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
- •History of rheumatic fever
- •Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
- •HIV infection or born to an HIV positive mother
- •Kawasaki disease
- •Immunologic disease
- •Uremia, active or chronic
- •Abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia
- •10.Chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose cardiomyopathy persists after two months is not to be excluded) 11.Malignancy 12.Pulmonary parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary hypertension) 13.Ischemic coronary vascular disease 14.Association with drugs (e.g., growth hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy
结局指标
主要结局
Result of echocardiography
时间窗: three year
The whole results of echocardiography report will be recorded. The indicates whi ch can reflect cardiac function including Left ventricular ejection fraction, left ventricular end diastolic diameter, E/A ratio of bicuspid valve will be used to calculate the association with metabolites.
次要结局
- Cardiovascular death(One year/Three year)
- Heart transplantation(One year/Three year)
- Re-hospitalization(One year/Three year)
- malignant arrythmia(One year/Three year)
- Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of plasma sample(The data is collected from lab in an average of 3 month after the sample recruiting)
- Worsening heart failure(These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting)