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Feasibility of Improving Risk Stratification in Brugada Syndrome (FIRST-BrS)

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ClinicalTrials.gov Identifier: NCT03992677
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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


Condition or disease Intervention/treatment
Brugada Syndrome Cardiac Arrest Athletes Heart Atrial Fibrillation Ventricular Ectopic Beat Other: No intervention

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Feasibility of Improving Risk Stratification in Brugada Syndrome
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020


Group/Cohort Intervention/treatment
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
No intervention

Brugada relative
Relatives of Brugada syndrome patients with proven no pathology by Ajmaline challenge
Other: No intervention
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
No intervention

AF
Patients with AF undergoing ablation with ECGi system (n=10). These patients will be older and have varying RR intervals which may cause a falsely low V-CoS.
Other: No intervention
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
No intervention

Athletes
Athletic Hypertrophy (n=10) - Elite athletes often have physiological LVH and abnormal ECGs at rest. It is unclear if these variations in activation will lead to a decrease in V-CoS.
Other: No intervention
No intervention




Primary Outcome Measures :
  1. V-CoS [ Time Frame: 3 years ]
    Minimum V-CoS score between exercise and rest



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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. Patient with AF undergoing ablation with ECGi system
    3. Relatives of Brugada patients with confirmation of no pathology
    4. Out-of-hospital cardiac arrest primary PCI with full recovery of left ventricular function and full revascularisation (n=10)
    5. Athletic Hypertrophy (n=10)
Criteria

INCLUSION CRITERIA

  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. Patient with AF undergoing ablation with ECGi system
    3. Relatives of Brugada patients with confirmation of no pathology
    4. Out-of-hospital cardiac arrest primary PCI with full recovery of left ventricular function and full revascularisation (n=10)
    5. Athletic Hypertrophy (n=10)

EXCLUSION CRITERIA

  1. Pregnancy or not using a highly effective form of contraception
  2. Patients unable to exercise
  3. Patients unable to provide consent
  4. Patients who have contraindications to an electrophysiological study.
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992677


Contacts
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Contact: Prapa Kanagaratnam, PhD, FRCP 020 3313 1000 p.kanagaratnam@ic.ac.uk
Contact: Ji-Jian Chow, MRCP 020 3313 1000 ji-jian.chow09@imperial.ac.uk

Locations
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United Kingdom
Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Ji-Jian Chow    020 3313 1000    ji-jian.chow09@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
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Study Director: Ruth Nicholson Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03992677     History of Changes
Other Study ID Numbers: 17SM4046
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Brugada Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn