An Integrative-"Omics" Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China

NCT ID: NCT03076580

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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:

1. Proteomics, microRNA-seq and metabolomics will be to determine the correlation of echocardiographic parameters of systolic and diastolic functional entry with circulating molecules
2. Genomics will be to determine the association of clinical outcome

Conditions

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Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy Left Ventricular Non-compaction Restrictive Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cardiomyopathy

Patients are diagnosed as cardiomyopathy by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.

No interventions assigned to this group

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.

No interventions assigned to this group

healthy control

Healthy subjects are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
2. Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures.

Exclusion Criteria

1. Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
2. History of rheumatic fever
3. Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
4. HIV infection or born to an HIV positive mother
5. Kawasaki disease
6. Immunologic disease
7. Uremia, active or chronic
8. Abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Beijing Institute of Heart, Lung and Blood Vessel Diseases

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Du, PhD

Role: STUDY_CHAIR

Beijing Anzhen Hospital affiliated to Capital Medical University

Locations

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Beijing Institute of heart, lung and blood vessel diseases

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Institute of heart, lung and blood vessel diseases

Beijing, Beijing Municipality, China

Site Status RECRUITING

Shijie You

Beijing, , China

Site Status ENROLLING_BY_INVITATION

Countries

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China

Central Contacts

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Jie Du, PhD

Role: CONTACT

Yulin Li, PhD

Role: CONTACT

Facility Contacts

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Jie Du

Role: primary

Yulin Li

Role: backup

Jie Du

Role: primary

Yulin Li

Role: backup

Other Identifiers

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BeijingIHLBVD2016031

Identifier Type: -

Identifier Source: org_study_id

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