Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-07 @ 5:47 PM
Study NCT ID:
NCT01792960
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry and Prevalence of Gene Mutation in Korean Patients With Familial Hypertrophic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024741', 'term': 'Cardiomyopathy, Hypertrophic, Familial'}], 'ancestors': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, whole blood, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-17', 'studyFirstSubmitDate': '2013-02-07', 'studyFirstSubmitQcDate': '2013-02-13', 'lastUpdatePostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1) DNA analysis', 'timeFrame': '1 year', 'description': '1\\) Identify susceptible genes for familial hypertrophic cardiomyopathy in Korean'}], 'secondaryOutcomes': [{'measure': '2) Prognosis of familial hypertrophic cariomyopathy', 'timeFrame': '1 year', 'description': '2\\) all-cause mortality, hospitalization for heart failure progression, stroke, heart transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Familial Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence of gene mutations in Korean patients with familial hypertrophic cardiomyopathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'familial hypertrophic cardiomyopathy patients and their relatives', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. left ventricular maximal wall thickness ≥ 15mm on echocardiography\n2. hypertrophic cardiomyopathy patients' relatives\n\nExclusion Criteria:\n\n1. other cardiomyopathy or systemic disease (e.g. fabry disease, danon disease, glycogen storage disease)\n2. who deny the study entrance, especially in patients' relatives"}, 'identificationModule': {'nctId': 'NCT01792960', 'briefTitle': 'Registry and Prevalence of Gene Mutation in Korean Patients With Familial Hypertrophic Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2012-0869'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'familial hypertrophic cardiomyopathy', 'description': 'familial hypertrophic cardiomyopathy patients and their relatives'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}