Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04304118
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2020-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rajaie Cardiomyopathy and Myocarditis Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2025-11-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-07', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-03-07', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Admissions to hospital', 'timeFrame': '1 year', 'description': 'Number of hospitalizations for cardiovascular reasons'}, {'measure': 'Development of chronic heart failure', 'timeFrame': '1 year', 'description': 'significant decrease in left ventricular ejection fraction'}, {'measure': 'Prevalence of Stroke/Transient ischemic attack', 'timeFrame': '1 year', 'description': 'At least 80% CT/MRI verification of the diagnosis of ischemic stroke/Transient ischemic attack, within the first week of stroke onset'}, {'measure': 'Incidence of sudden death', 'timeFrame': '1 year', 'description': 'unexpected death from a cardiovascular cause in a person with or without preexisting heart disease'}, {'measure': 'Incidence of heart trasplantation', 'timeFrame': '1 year', 'description': 'Cardiac transplantation in patients with end-stage HF who remain symptomatic despite optimal medical therapy'}], 'secondaryOutcomes': [{'measure': 'response to current therapeutic approaches', 'timeFrame': '1 year', 'description': 'Implantable cardioverter defibrillator implantation, Cardiac resynchronisation therapy, septal myectomy, ablation, cardiac transplantation and medications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Characteristics', 'Natural History', 'Long-term Outcomes', 'Current Therapeutic Approaches']}, 'descriptionModule': {'briefSummary': 'The prevalence of patients with cardiomyopathies who referred to Rajaei Cardiovascular medical and research center is remarkable, and also the mission of this center is to achieve center of excellence in the field of cardiomyopathy. Rajaie Cardiomyopathy and myocarditis Registry study is an observational registry of consecutive patients with four cardiomyopathy subtypes: hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), and restrictive cardiomyopathy (RCM) as well as myocarditis designed to determine clinical characteristics, natural history, current therapeutic approaches, response to treatment and long-term outcomes of patients with cardiomyopathy and myocarditis and to address limitations in extant evidence to improve prognostication in cardiomyopathies and myocarditis. Prediction of mortality and response to different treatments in these patients using artificial intelligence is another aim of this registry'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria based on the ESC guideline for cardiomyopathy/ myocarditis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age greater than one year\n2. documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria\n3. able to give informed consent or in the case of child consent from a parent\n\nExclusion Criteria:\n\nPatients who have not consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04304118', 'briefTitle': 'Rajaie Cardiomyopathy and Myocarditis Registry', 'organization': {'class': 'OTHER', 'fullName': 'Rajaie Cardiovascular Medical and Research Center'}, 'officialTitle': 'Rajaie Cardiomyopathy and Myocarditis Registry', 'orgStudyIdInfo': {'id': 'registry_98118'}}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Behshid Ghadrdoost, PhD', 'role': 'CONTACT', 'email': 'behshid.ghadrdoost@yahoo.com', 'phone': '+982123923017'}], 'facility': 'Behshid Ghadrdoost', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Behshid Ghadrdoost, PhD', 'role': 'CONTACT', 'email': 'behshid.ghadrdoost@yahoo.com', 'phone': '+982123923017'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rajaie Cardiovascular Medical and Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}