NCT03076580Unknown不适用
An Integrative-omics Study to Identify New Biomarkers of Cardiomyopathy Patients in China
Beijing Institute of Heart, Lung and Blood Vessel Diseases2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy.
研究概览
简要总结
This is a multi-omics research of Chinese cardiomyopathies patients, aiming to determine genetic risk factor and serial biomarkers of cardiomyopathies in diagnosis and prognosis.
详细描述
Identification of novel biomarkers is needed to improve the diagnosis and prognosis of cardiomyopathy. Also,the marked variation of genes which is still unclear, may influence clinical outcomes is determined in part by genetic heterogeneity of the systemic response to pathological process.
Specific aim:
- Proteomics, microRNA-seq and metabolomics will be to determine the correlation of echocardiographic parameters of systolic and diastolic functional entry with circulating molecules
- Genomics will be to determine the association of clinical outcome
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
The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy.
时间窗: Five year
The primary objective of this study is to determine whether variation in genetic background or molecules influences clinical outcomes in cardiomyopathy. Differentially expressed molecules are reported in multi-omics.
次要结局
- Height for each participant(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- Weight for each participant(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- Past medical history for each participant including disease history, surgical history, and family(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- hsCRP(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- Re-hospitalization(One year/Three year/Five year)
- Proteomics on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer of plasma sample(The data is collected from lab in an average of 6 month after the sample recruiting)
- Age for each participant(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- Malignant arrythmia(One year/Three year/Five year)
- gender for each participant(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- Life style for each participant including smoking history and drinking, specify how many years(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- blood glucose(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- Exon sequencing data(The data is collected from lab in an average of 6 month after the sample recruiting)
- Result of echocardiography-Left Ventricular End Diastolic Diameter(Three year)
- Result of echocardiography-E/A Ratio(Three year)
- blood lipids(LDL,HDL,VLDL)(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- creatine(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- urea(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- RNA/micro RNA/long-noncoding RNA-sequencing data(The data is collected from lab in an average of 6 month after the sample recruiting)
- D-dimer(These data is collected from the cases' medical record in an average of 1 month after the sample recruiting)
- All-cause death(One year/Three year/Five year)
- Heart transplantation(One year/Three year/Five year)
- Worsening heart failure(One year/Three year/Five year)
- Result of echocardiography-Ejection Fraction(Three year)
研究者
研究点 (2)
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