The Conus Brugada Syndrome Study | NCT06653504

Studies
The Conus Brugada Syndrome Study

NCT06653504

Sponsor

Barts & The London NHS Trust

Status

Completed

Last Update Posted

Oct 22, 2024Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Brugada Syndrome

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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)

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2018Actual

Primary Completion Date

Nov 6, 2020Actual

Completion Date

Nov 6, 2020Actual

First Submitted Date

Oct 21, 2024

First Submission Date that Met QC Criteria

Oct 21, 2024

First Posted Date

Oct 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2024

Last Update Posted Date

Oct 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pier Lambiase, PhD FRCP FHRS	Barts & The London NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barts Health NHS Trust		London		EC1A 7BE	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D053840	Brugada Syndrome

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

Browse Leaves

Not provided

Browse Branches

Not provided