Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-26 @ 5:41 PM
Study NCT ID:
NCT06653504
Status:
COMPLETED
Last Update Posted:
2024-10-22
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Conus Brugada Syndrome Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053840', 'term': 'Brugada Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ECG and/or electrogram changes', 'timeFrame': 'During Procedure', 'description': 'Incidence of ECG changes resembling a Brugada type 1 pattern of coved ST elevation (one of the three Brugada types) specifically significant J point elevation in the precordial leads (V1-V3) and/or electrogram changes on the epicardial and/or endocardial intracardiac traces which will then be compared for differences and evidence of a transmural voltage gradient existing between them.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brugada Syndrome']}, 'descriptionModule': {'briefSummary': 'An observational, analytical, cross sectional study investigating the effects of Conus branch and Right Ventricular (RV) Branch occlusion on surface ECG and intra-cardiac electrograms in patients undergoing percutaneous coronary intervention (PCI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Patients aged at least 18 years who have a chronic total occlusion of the RCA with no significant anterior ST elevation prior to an elective CTO procedure.\n2. A Conus branch and or RV branch present to deploy an anchor balloon.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18-85\n* Patients able and willing to give their written informed consent.\n* Planned PCI of a CTO of a right coronary artery\n* Planned use of an anchor balloon in the Conus branch or RV branch\n\nExclusion Criteria:\n\n* Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures).\n* Patients with a pre-existing, confirmed or possible diagnosis of Brugada Syndrome\n* Marked ST elevation or J point elevation on baseline (prior to procedure) ECG in the precordial leads (V1-V3)\n* Pregnancy. This will be tested by urine HcG measurement"}, 'identificationModule': {'nctId': 'NCT06653504', 'acronym': 'Conus-BRS', 'briefTitle': 'The Conus Brugada Syndrome Study', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'The CONUS-BRS STUDY: An Observational, Analytical, Cross Sectional Study Investigating the Effects of Conus Branch and Right Ventricular (RV) Branch Occlusion on Surface ECG and Intra-cardiac Electrograms in Patients Undergoing Percutaneous Coronary Intervention (PCI)', 'orgStudyIdInfo': {'id': 'Version 1 08/12/2016'}}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Pier Lambiase, PhD FRCP FHRS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts & The London NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}