Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-22 @ 7:16 AM
Study NCT ID:
NCT03061994
Status:
UNKNOWN
Last Update Posted:
2017-05-30
First Post:
2017-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomic Study of All-age Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D019571', 'term': 'Arrhythmogenic Right Ventricular Dysplasia'}, {'id': 'D002313', 'term': 'Cardiomyopathy, Restrictive'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2017-02-06', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Result of echocardiography', 'timeFrame': 'three year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular death', 'timeFrame': 'One year/Three year', 'description': 'The data is collected during follow-up visit at 1/3 years after discharge'}, {'measure': 'Re-hospitalization', 'timeFrame': 'One year/Three year', 'description': 'patients are hospitalized due to heart failure with decreasing left ventricular ejection fraction (LVEF) or worsen symptoms. The data is collected during follow-up visit at 1/3 years after discharge'}, {'measure': 'Heart transplantation', 'timeFrame': 'One year/Three year', 'description': 'patients are hospitalized due to heart failure.The data is collected during follow-up visit at 1/3 years after discharge'}, {'measure': 'malignant arrythmia', 'timeFrame': 'One year/Three year', 'description': 'Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.'}, {'measure': 'Worsening heart failure', 'timeFrame': "These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting", 'description': '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 months after enrollment.'}, {'measure': 'Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of plasma sample', 'timeFrame': 'The data is collected from lab in an average of 3 month after the sample recruiting', 'description': 'The results of metabolomics will be measured by mass spectrometry, including lipids, sugars and amino acids. All of metabolites will be quantitative(unit:mol/L). Identification of molecules via Human Metabolites Database will be reported online.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dilated Cardiomyopathy', 'Hypertrophic Cardiomyopathy', 'Arrhythmogenic Right Ventricular Cardiomyopathy', 'Left Ventricular Non-compaction', 'Restrictive Cardiomyopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A diagnosis of cardiomyopaty is adjudicated by three cardiologists,according to current guidelines when there was clinical evidence of cardiomyopathy together with clinical symptoms of heart failure or echocardiography or imaging evidence.\n\nage- and gender- mathced healthy controls are also recuitted in the hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.\n2. Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures\n\nExclusion Criteria:\n\n1. Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)\n2. History of rheumatic fever\n3. Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)\n4. HIV infection or born to an HIV positive mother\n5. Kawasaki disease\n6. Immunologic disease\n7. Uremia, active or chronic\n8. Abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia\n\n10.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'}, 'identificationModule': {'nctId': 'NCT03061994', 'acronym': 'MAC', 'briefTitle': 'Metabolomic Study of All-age Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases'}, 'officialTitle': 'Metabolomic Study of Patients With Cardiomyopathy in China', 'orgStudyIdInfo': {'id': 'BeijingIHLBVD2016023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiomyopathy', 'description': 'Children(older than 18 years old) are diagnosed as cardiomyopathy by three cardiologists and recruited in pediatric heart center,Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.\n\nAdults are diagnosed as cardiomyopathy by three cardiologists and recruited in the department of cardiology ,Beijing Anzhen Hospital.'}, {'label': 'Control', 'description': 'Healthy children and adults are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Du, PhD', 'role': 'CONTACT', 'email': 'jiedubj@126.com'}, {'name': 'Yulin Li, PhD', 'role': 'CONTACT', 'email': 'lyllyl_1111@163.com'}, {'name': 'Hongzhao You', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beijing Institute of heart, lung and blood vessel diseases', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jie Du, PhD', 'role': 'CONTACT', 'email': 'jiedubj@126.com'}, {'name': 'Hongzhao You', 'role': 'CONTACT', 'email': 'hongzhao_you@163.com'}], 'overallOfficials': [{'name': 'Yulin Li, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing anzhen hospital affiliated to capital medical university'}, {'name': 'Yongqiang Lai, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing anzhen hospital affiliated to capital medical university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}