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OpenTrials
Completed

NCT Number: NCT06653504

The Conus Brugada Syndrome 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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. ECG and/or electrogram changes

    Time frame: During Procedure

    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.

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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)

Acronym: Conus-BRS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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