Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT03224156
Status:
UNKNOWN
Last Update Posted:
2017-07-27
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], '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': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Combined Endpoint', 'timeFrame': '18 months', 'description': 'Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '18 months', 'description': 'Cardiac Death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiomyopathy, Dilated', 'Sudden Cardiac Death']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.heidelberg-university-hospital.com/', 'label': 'University Hospital Heidelberg'}]}, 'descriptionModule': {'briefSummary': 'PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.', 'detailedDescription': 'Prophylactic ICD implantation was recently found to be non-beneficial over usual clinical care in non-ischemic systolic heart failure (LVEF≤35%) and 60-70% percent of SCD cases even occur in individuals with LEVF\\>35%. A growing evidence, that emphasizes the urgent need to improve the prediction of sudden cardiac death (SCD) in dilated cardiomyopathy (DCM).\n\nCMR provides unique information on myocardial mechanics, fibrotic burden, inflammation and microvascular dysfunction, thereby allowing to quantify key substrates for myocardial arrhythmogenic potential.\n\nPREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.\n\nAcquired candidate predictors are among others:\n\n* Global and regional T1/T2\n* T1/T2 inhomogeneity\n* Extracellular volume fraction\n* Microvascular dysfunction\n* LA function and filling fraction\n* Global and regional circumferential, radial or longitudinal myocardial strain\n* Biomarkers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Dilated Cardiomyopathy prior to ICD-implantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dilated Cardiomyopathy\n* ICD Indication\n* age ≥ 18 years\n* signed informed consent\n\nExclusion Criteria:\n\n* severe claustrophobia\n* rest dyspnea\n* tachycardia or severe arrhythmia\n* intolerance to gadolinium-based contrast agent'}, 'identificationModule': {'nctId': 'NCT03224156', 'acronym': 'PREDICT-DCM', 'briefTitle': 'Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy: The PREDICT-DCM Trial.', 'orgStudyIdInfo': {'id': 'S-281/2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dilated Cardiomyopathy', 'interventionNames': ['Diagnostic Test: Cardiac Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Cardiac Magnetic Resonance Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.', 'armGroupLabels': ['Dilated Cardiomyopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marco M Ochs, Dr. med.', 'role': 'CONTACT'}], 'facility': 'University Hospital Heidelberg, Krehl Klinik, Department of Cardiology', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '69469', 'city': 'Weinheim', 'state': 'Baden-Wurttemberg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sorin Giusca, Dr. med.', 'role': 'CONTACT'}], 'facility': 'GRN Hospital Weinheim', 'geoPoint': {'lat': 49.54887, 'lon': 8.66697}}], 'centralContacts': [{'name': 'Marco M Ochs, Dr. med.', 'role': 'CONTACT', 'email': 'marco.ochs@med.uni-heidelberg.de', 'phone': '00496221-568611'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Marco Ochs', 'investigatorFullName': 'Marco Ochs', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}