Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-27 @ 11:17 AM
Study NCT ID:
NCT05871632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-23
First Post:
2023-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The China CardioMyopathy Registry Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-13', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-05-13', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of participants with cardiovascular deaths', 'timeFrame': 'an average of 1 year', 'description': 'including sudden cardiac death and deaths due to heart failure and stroke'}], 'secondaryOutcomes': [{'measure': 'number of participants with heart failure', 'timeFrame': 'an average of 1 year', 'description': 'progress to level III or IV in New York Heart Association class'}, {'measure': 'number of participants with stroke', 'timeFrame': 'an average of 1 year', 'description': 'including cerebral infraction and hemorrhage'}, {'measure': 'number of participants with myocardial infarction', 'timeFrame': 'an average of 1 year', 'description': 'including ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction'}, {'measure': 'number of participants with all-cause deaths', 'timeFrame': 'an average of 1 year', 'description': 'including deaths due to any causes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiomyopathies']}, 'descriptionModule': {'briefSummary': 'Cardiomyopathy is the most common inherited cardiovascular disease, showing family aggregation, so it has a huge psychological and economic burden on family members. Studying the clinical characteristics of patients with cardiomyopathy is helpful for further diagnosis, treatment and management, which has important clinical and social significance.', 'detailedDescription': 'In this study, patients hospitalized with cardiomyopathy as the primary discharge diagnosis in China are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. Data are collected with the use of case report forms (CRFs) and are entered into a web-based system. A 6 mL venous blood sample is obtained from consenting patients. Each participant is scheduled to be followed up by telephone every 12 months after admission to hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized with cardiomyopathy as the primary discharge diagnosis are recruited prospectively from multiple centers in China between July 1, 2023 and June 30, 2025.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary discharge diagnosis meeting one of the following subtypes of cardiomyopathy were enrolled, including HCM, DCM, ACM, RCM, left ventricular non-compaction, cardiac amyloidosis, Fabry disease, Pompe disease, Danon disease, and PRKAG2 cardiac syndrome.\n\nExclusion Criteria:\n\n* Patients who refuse to sign the informed consent or decline follow-up.'}, 'identificationModule': {'nctId': 'NCT05871632', 'acronym': 'CHINA-CM', 'briefTitle': 'The China CardioMyopathy Registry Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'The China CardioMyopathy Registry Study', 'orgStudyIdInfo': {'id': 'CHINA-CM'}}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Song, MD.&phD', 'role': 'CONTACT', 'email': 'clinicalfw@163.com', 'phone': '86-13810532620'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Lei.Song,MD.&ph.D', 'investigatorAffiliation': 'China National Center for Cardiovascular Diseases'}}}}