Feasibility of Improving Risk Stratification in Brugada Syndrome

NCT03992677 | Completed

• 1 other identifier: 17SM4046
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility of Improving Risk Stratification in Brugada Syndrome (BrS), retrospective cohort study To study the reproducibility and specificity of V-CoS for activation heterogeneities predisposing to VT/VF in a larger series of BrS patients and determining the incidence of low V-CoS score in a larger cohort of control patients. Population of 10 patients undergoing ablation for non-VT arrhythmia, 10 patients with atrial fibrillation, 10 relatives of BrS sufferers, who have confirmation of no pathology,10 patients with previous out-of-hospital cardiac arrest due to ischaemia, but with full revascularisation and recovery of left ventricular function, 10 elite athletes, 50 BrS sufferers with previous sudden cardiac death or appropriate Implantable cardioverter-defibrillator (ICD) therapy for VT/VF. DURATION 3 years

Conditions

Brugada Syndrome; Cardiac Arrest; Athletes Heart; Atrial Fibrillation; Ventricular Ectopic Beat

Keywords

Brugada Syndrome; Ventricular Ectopic Beat

Outcome Measures

Primary Outcomes (1)

• Minimum of Ventricular Conduction Stability (V-CoS) score

  Method to identify and quantify changes in whole heart activation patterns during physiological stress, V-CoS score between exercise and rest. Test assigns a V-CoS score of '100' when conduction patterns at peak exercise is the same as at rest.

  3 years

Study Arms (4)

Brugada VF

Confirmed Brugada Syndrome by either Spontaneous or drug induced Type 1 ECG, confirmed cardiac arrest or appropriate ICD therapy for potentially lethal arrhythmia.

Other: No intervention

Brugada relative

Relatives of Brugada syndrome patients with proven no pathology by Ajmaline challenge

Other: No intervention

Ventricular ectopy

Patients undergoing ablation with ECGi system for other arrhythmias -these patients will be similar to our original controls and provide a repeat set of controls.

Other: No intervention

Ischaemic VF

Out-of-hospital cardiac arrest primary PCI with full recovery of left ventricular function and full revascularisation (n=10) - the purpose of this group is to confirm that the changes detected in our SCD group are not secondary to the SCD event. These are patients who have had a cardiac arrest secondary to coronary occlusion, but have made a full recovery with normal LGE-MRI and no indication for ICD.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Brugada VF; Brugada relative; Ischaemic VF; Ventricular ectopy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients with Brugada syndrome requiring risk stratification 2. Patients without Brugada syndrome acting as a control group 1. Patients undergoing ablation with ECGi system for other arrhythmias 2. Relatives of Brugada patients with confirmation of no pathology 3. Out-of-hospital cardiac arrest primary PCI with full recovery of left ventricular function and full revascularisation (n=10)

You may qualify if:

• Patients with Brugada syndrome requiring risk stratification
• Patients without Brugada syndrome acting as a control group
• Patients undergoing ablation with ECGi system for other arrhythmias
• Relatives of Brugada patients with confirmation of no pathology
• Out-of-hospital cardiac arrest primary PCI with full recovery of left ventricular function and full revascularisation (n=10)

You may not qualify if:

• Pregnancy or not using a highly effective form of contraception
• Patients unable to exercise
• Patients unable to provide consent
• Patients who have contraindications to an electrophysiological study.
• Patients with no Brugada syndrome that are known to be high-risk for SCD for another reason e.g. Hypertrophic cardiomyopathy, ischaemic cardiomyopathy with severely impaired left ventricular function.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Brugada Syndrome; Heart Arrest; Atrial Fibrillation; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature

Study Officials

• Ruth Nicholson

  Imperial College London

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: June 20, 2019
• Study Start: December 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: August 1, 2022
• Last Updated: August 17, 2022

Record last verified: 2021-09

Locations

GB (1)