Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02291393
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2014-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019571', 'term': 'Arrhythmogenic Right Ventricular Dysplasia'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-18', 'studyFirstSubmitDate': '2014-11-11', 'studyFirstSubmitQcDate': '2014-11-11', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QRS wave dispersion in an ECG', 'timeFrame': '5 minutes', 'description': 'The difference in QRS wave dispersion between the right and left ventricular leads'}]}, 'conditionsModule': {'conditions': ['Arrhythmogenic Right Ventricular Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80 lead ECG may increase the specificity and sensitivity in diagnosing this potentially life threatening inherited cardiac condition. This pilot would form the basis of a much larger clinical trial to test the utility of this novel diagnostic tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of arrhythmogenic right ventricular cardiomyopathy who are being followed up in the cardiology clinic\n\nExclusion Criteria:\n\n* Inability to consent\n* Pacing dependent patients\n* Other concomitant cardiag disease e.g. coronary artery disease\n* Atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT02291393', 'briefTitle': 'The Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'The Role of High Density Surface Cardiac Electrographic Mapping in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy :A Pilot Study', 'orgStudyIdInfo': {'id': 'CD12/10936'}, 'secondaryIdInfos': [{'id': '12/YH/0346', 'type': 'OTHER', 'domain': 'Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient', 'description': 'Patients with previously confirmed Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)', 'interventionNames': ['Device: 80 lead ECG']}, {'type': 'OTHER', 'label': 'Healthy volunteers', 'description': 'Aged and gender matched healthy controls.', 'interventionNames': ['Device: 80 lead ECG']}], 'interventions': [{'name': '80 lead ECG', 'type': 'DEVICE', 'armGroupLabels': ['Healthy volunteers', 'Patient']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}