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Brugada Syndrome and Artificial Intelligence Applications to Diagnosis

NCT ID: NCT04641585

Last Updated: 2020-11-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2023-09-15

Brief Summary

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Aim of the project is the development of an integrated platform, based on machine learning and omic techniques, able to support physicians in as much as possible accurate diagnosis of Type 1 Brugada Syndrome (BrS).

Detailed Description

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The aim of BrAID project is to integrate classic clinical guidelines for Brugada Syndrome 1 diagnosis evaluation with innovative Information and Communication Technologies and omic approaches, generating new diagnostic strategies in cardiovascular precision medicine of this disease.

Conditions

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Brugada Syndrome 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients affected by Brugada Syndrome 1

Patients with spontaneous or drug-induced Brugada Syndrome 1

Group Type EXPERIMENTAL

Patients affected by Brugada Syndrome 1

Intervention Type DIAGNOSTIC_TEST

ECG analysis by Machine Learning algorithms and blood collection for the transcriptomic study of markers possibly associated with the disease

Controls

Patients with no condition associated with spontaneous or drug-induced Brugada Syndrome 1

Group Type ACTIVE_COMPARATOR

Patients affected by Brugada Syndrome 1

Intervention Type DIAGNOSTIC_TEST

ECG analysis by Machine Learning algorithms and blood collection for the transcriptomic study of markers possibly associated with the disease

Interventions

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Patients affected by Brugada Syndrome 1

ECG analysis by Machine Learning algorithms and blood collection for the transcriptomic study of markers possibly associated with the disease

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Brugada patients: patients with Brugada Syndrome 1 spontaneous or induced by the ajmaline test; patients with non-diagnostic electrocardiographic pattern for Brugada Syndrome 1 or negative in the presence of high clinical suspicion (family history for Brugada Syndrome, patients who survived cardiac arrest without organic heart disease)
* Control patients: patients with frequent premature ventricular complex and normal left and right ventricular function; patients with suspected Brugada Syndrome 1 not confirmed by ajmaline test

Exclusion Criteria

* organic heart disease or diseases interfering with protocol completion
* lack of signed informed consent
* pregnancy
* acute coronary artery disease, heart failure in the previous 3 months
* severe renal or liver failure
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Toscana Gabriele Monasterio

OTHER

Sponsor Role collaborator

Azienda USL Toscana Sud Est

OTHER_GOV

Sponsor Role collaborator

Azienda USL Toscana Nord Ovest

OTHER

Sponsor Role collaborator

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role collaborator

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role collaborator

Istituto di Fisiologia Clinica CNR

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Federico Vozzi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Istituto di Fisiologia Clinica

Locations

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Azienda USL Toscana Sud Est - U.O.C Cardiologia

Arezzo, Tuscany, Italy

Site Status

Azienda Ospedaliera Universitaria Careggi - SOD Aritmologia

Florence, Tuscany, Italy

Site Status

Azienda Ospedaliero Universitaria Pisana - Cardiologia 2

Pisa, Tuscany, Italy

Site Status

Fondazione Toscana Gabriele Monasterio

Pisa, Tuscany, Italy

Site Status

Istituto di Fisiologia Clinica IFC-CNR

Pisa, Tuscany, Italy

Site Status

Azienda Usl Toscana Nord Ovest - U.O.C. Cardiologia

Viareggio, Tuscany, Italy

Site Status

Countries

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Italy

Central Contacts

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Giorgio Iervasi, Dr.

Role: CONTACT

Phone: +390503153302

Email: [email protected]

Facility Contacts

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Pasquale Giovanni Notarstefano, Dr.

Role: primary

Paolo Pieragnoli, Dr.

Role: primary

Giulio Zucchelli, Dr.

Role: primary

Marcello Piacenti, Dr.

Role: primary

Federico Vozzi, Ph.D.

Role: primary

Maria-Aurora Morales, Dr.

Role: backup

Gianluca Solarino, Dr.

Role: primary

References

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Brugada P, Brugada J. Right bundle branch block, persistent ST segment elevation and sudden cardiac death: a distinct clinical and electrocardiographic syndrome. A multicenter report. J Am Coll Cardiol. 1992 Nov 15;20(6):1391-6. doi: 10.1016/0735-1097(92)90253-j.

Reference Type BACKGROUND
PMID: 1309182 (View on PubMed)

Quan XQ, Li S, Liu R, Zheng K, Wu XF, Tang Q. A meta-analytic review of prevalence for Brugada ECG patterns and the risk for death. Medicine (Baltimore). 2016 Dec;95(50):e5643. doi: 10.1097/MD.0000000000005643.

Reference Type BACKGROUND
PMID: 27977610 (View on PubMed)

Vutthikraivit W, Rattanawong P, Putthapiban P, Sukhumthammarat W, Vathesatogkit P, Ngarmukos T, Thakkinstian A. Worldwide Prevalence of Brugada Syndrome: A Systematic Review and Meta-Analysis. Acta Cardiol Sin. 2018 May;34(3):267-277. doi: 10.6515/ACS.201805_34(3).20180302B.

Reference Type BACKGROUND
PMID: 29844648 (View on PubMed)

Antzelevitch C, Brugada P, Borggrefe M, Brugada J, Brugada R, Corrado D, Gussak I, LeMarec H, Nademanee K, Perez Riera AR, Shimizu W, Schulze-Bahr E, Tan H, Wilde A. Brugada syndrome: report of the second consensus conference. Heart Rhythm. 2005 Apr;2(4):429-40. doi: 10.1016/j.hrthm.2005.01.005.

Reference Type BACKGROUND
PMID: 15898165 (View on PubMed)

Wilde AA, Antzelevitch C, Borggrefe M, Brugada J, Brugada R, Brugada P, Corrado D, Hauer RN, Kass RS, Nademanee K, Priori SG, Towbin JA; Study Group on the Molecular Basis of Arrhythmias of the European Society of Cardiology. Proposed diagnostic criteria for the Brugada syndrome. Eur Heart J. 2002 Nov;23(21):1648-54. doi: 10.1053/euhj.2002.3382. No abstract available.

Reference Type BACKGROUND
PMID: 12448445 (View on PubMed)

Sarquella-Brugada G, Campuzano O, Arbelo E, Brugada J, Brugada R. Brugada syndrome: clinical and genetic findings. Genet Med. 2016 Jan;18(1):3-12. doi: 10.1038/gim.2015.35. Epub 2015 Apr 23.

Reference Type BACKGROUND
PMID: 25905440 (View on PubMed)

Morales MA, Piacenti M, Nesti M, Solarino G, Pieragnoli P, Zucchelli G, Del Ry S, Cabiati M, Vozzi F. The BrAID study protocol: integration of machine learning and transcriptomics for brugada syndrome recognition. BMC Cardiovasc Disord. 2021 Oct 13;21(1):494. doi: 10.1186/s12872-021-02280-3.

Reference Type DERIVED
PMID: 34645390 (View on PubMed)

Other Identifiers

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BrAID

Identifier Type: -

Identifier Source: org_study_id