Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Ajmaline 17-(Chloroacetate) Monohydrochloride
- Conditions
- Brugada Syndrome
- Sponsor
- IRCCS Policlinico S. Donato
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Electrocardiographic changes
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The study purpose is to evaluate the morphological, functional and electrophysiological characteristics of the right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome as well as to correlate CMR findings and substrate size.
Detailed Description
All consecutive patients with either spontaneous or ajmaline-induced BrS-ECG pattern will be screened. A total of 30 BrS patients and 30 normal age, sex and BSA matched normal controls will be selected and enrolled. Patients will perform cardiac magnetic resonance imaging to evaluate and compare morphological and functional characteristics of the 2 groups before and after ajmaline. BrS patients will also perform a standardized programmed ventricular stimulation protocol and electroanatomical mapping to determine the substrate size.
Investigators
Carlo Pappone
Head of Arrhythmology Department
IRCCS Policlinico S. Donato
Eligibility Criteria
Inclusion Criteria
- •Brugada syndrome with either spontaneous or ajmaline- induced type 1 ECG pattern
- •Indication to ajmaline testing and programmed ventricular stimulation
- •Age \> or equal to 18 years
- •Written informed consent
Exclusion Criteria
- •Pregnancy
- •Contraindication to CMRI or to ajmaline
- •Live espectance \< 12 months
Arms & Interventions
BrS Group
Ajmaline 17-(Chloroacetate) Monohydrochloride
Intervention: Ajmaline 17-(Chloroacetate) Monohydrochloride
No BrS group
Ajmaline 17-(Chloroacetate) Monohydrochloride
Intervention: Ajmaline 17-(Chloroacetate) Monohydrochloride
Outcomes
Primary Outcomes
Electrocardiographic changes
Time Frame: 1 day during Electrocardiography
Changes of PR, QRS, and QT parameters, before and after ajmaline in Brugada patients as compared with control subjects
MRI changes of left and right ventricular function
Time Frame: 1day during MRI
MRI changes of left and right ventricular function before and after ajmaline in Brugada patients as compared with control subjects
CMR parameters changes of the right and left ventricle function
Time Frame: 1 day during CMR
Changes of right ventricular areal strain before and after ajmaline in Brugada patients as compared with controls
Electrical substrate changes of the right ventricle
Time Frame: 1 day after ICD implantation
electroanatomical epicardial mapping for substrate determination before and after ajmaline