Right Ventricle Morphology and Hemodynamics in BrS

NCT ID: NCT03524079

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-19

Study Completion Date

2019-11-09

Brief Summary

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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

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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.

Conditions

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Brugada Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BrS Group

Ajmaline 17-(Chloroacetate) Monohydrochloride

Ajmaline 17-(Chloroacetate) Monohydrochloride

Intervention Type DRUG

Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)

No BrS group

Ajmaline 17-(Chloroacetate) Monohydrochloride

Ajmaline 17-(Chloroacetate) Monohydrochloride

Intervention Type DRUG

Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)

Interventions

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Ajmaline 17-(Chloroacetate) Monohydrochloride

Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Carlo Pappone

Head of Arrhythmology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Pappone, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy

Locations

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IRCCS Policlinico S. Donato

San Donato Milanese, Milano, Italy

Site Status

Countries

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Italy

References

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Pappone C, Santinelli V, Mecarocci V, Tondi L, Ciconte G, Manguso F, Sturla F, Vicedomini G, Micaglio E, Anastasia L, Pica S, Camporeale A, Lombardi M. Brugada Syndrome: New Insights From Cardiac Magnetic Resonance and Electroanatomical Imaging. Circ Arrhythm Electrophysiol. 2021 Nov;14(11):e010004. doi: 10.1161/CIRCEP.121.010004. Epub 2021 Oct 25.

Reference Type DERIVED
PMID: 34693720 (View on PubMed)

Other Identifiers

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RV & BrS

Identifier Type: -

Identifier Source: org_study_id

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