The Conus Brugada Syndrome Study

NCT06653504 | Completed

• 1 other identifier: Version 1 08/12/2016
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Brugada Syndrome

Outcome Measures

Primary Outcomes (1)

• ECG and/or electrogram changes

  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.

  During Procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. 2. A Conus branch and or RV branch present to deploy an anchor balloon.

You may qualify if:

• Aged 18-85
• Patients able and willing to give their written informed consent.
• Planned PCI of a CTO of a right coronary artery
• Planned use of an anchor balloon in the Conus branch or RV branch

You may not qualify if:

• 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).
• Patients with a pre-existing, confirmed or possible diagnosis of Brugada Syndrome
• Marked ST elevation or J point elevation on baseline (prior to procedure) ECG in the precordial leads (V1-V3)
• Pregnancy. This will be tested by urine HcG measurement

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Brugada Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pier Lambiase, PhD FRCP FHRS

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: November 5, 2018
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

GB (1)