AOCC: An Integrative-"Omics" Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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:
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Proteomics, microRNA-seq and metabolomics will be to determine the correlation of echocardiographic parameters of systolic and diastolic functional entry with circulating molecules
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Genomics will be to determine the association of clinical outcome
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| cardiomyopathy Patients are diagnosed as cardiomyopathy by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. |
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| disease control Patients have similar symptoms with cardiomyopathy patients, and are further excluded by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. |
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| healthy control Healthy subjects are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination. |
Outcome Measures
Primary Outcome Measures
- The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy. [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.
Secondary Outcome Measures
- Age for each participant [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- gender for each participant [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- 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]
- 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 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]
- blood glucose [These data is collected from the cases' medical record in an average of 1 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]
- hsCRP [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]
The data is collected during follow-up visit at 1/3/5 years after discharge
- Re-hospitalization [One year/Three year/Five year]
Patients are hospitalized due to heart failure with decreasing left ventricular ejection fraction or worsen symptoms. The data is collected during follow-up visit at 1/3/5 years after discharge
- Heart transplantation [One year/Three year/Five year]
Patients are underwent heart transplantation due to "pump failure of heart".The data is collected during follow-up visit at 1/3 years after discharge
- Malignant arrythmia [One year/Three year/Five year]
Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.
- Worsening heart failure [One year/Three year/Five year]
Worsen heart failure is defined as decreased ejection fraction(left ventricular ejection fraction decreased over 10%), left ventricular ejection fraction <45% and enlarged heart size measured by echocardiography and changing level of New York Heart Association (NYHA) Functional Classification.And patients who undergo left ventricular assist device (LVAD) will also be included.The data is collected during follow-up visit at 3/6/9/12/36/60 months after enrollment.
- RNA/micro RNA/long-noncoding RNA-sequencing data [The data is collected from lab in an average of 6 month after the sample recruiting]
- 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]
- Exon sequencing data [The data is collected from lab in an average of 6 month after the sample recruiting]
- Result of echocardiography-Ejection Fraction [Three year]
The whole results of echocardiography report will be recorded. The indicate can reflect cardiac contraction function and be used for discriminating heart failure or non-heart failure as a main factor.
- Result of echocardiography-Left Ventricular End Diastolic Diameter [Three year]
The whole results of echocardiography report will be recorded. The indicate can reflect the size of heart and be used for determination of heart enlargement.
- Result of echocardiography-E/A Ratio [Three year]
The whole results of echocardiography report will be recorded. The indicate can reflect diastolic function.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
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Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures.
Exclusion Criteria:
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Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
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History of rheumatic fever
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Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
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HIV infection or born to an HIV positive mother
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Kawasaki disease
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Immunologic disease
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Uremia, active or chronic
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Institute of heart, lung and blood vessel diseases | Beijing | Beijing | China | |
| 2 | Beijing Institute of heart, lung and blood vessel diseases | Beijing | Beijing | China | |
| 3 | Shijie You | Beijing | China |
Sponsors and Collaborators
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Beijing Anzhen Hospital
Investigators
- Study Chair: Jie Du, PhD, Beijing Anzhen Hospital affiliated to Capital Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BeijingIHLBVD2016031