Brugada SyndromeConus-BRSNCT06653504
The Conus Brugada Syndrome Study
An observational study of Brugada Syndrome, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brugada Syndrome
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2018to 6 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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
- Medical subject headings
- Brugada Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start5 Nov 2018
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brugada SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Lambiase, PhD FRCP FHRS, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653504
- Sponsor's protocol ID
- Version 1 08/12/2016
- Acronym
- Conus-BRS
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06653504
- Acronym / sponsor ID
- Conus-BRS / Version 1 08/12/2016
- Conditions
- Brugada Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pier Lambiase, PhD FRCP FHRS principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG and/or electrogram changes (time frame: During Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.