Brugada Syndrome and Artificial Intelligence Applications to Diagnosis (BrAID)

National Research Council (CNR)

Status: Unknown

Conditions: Brugada Syndrome 1

Treatments: Diagnostic Test: Patients affected by Brugada Syndrome 1

Study type: Interventional

Funder types: Other

Identifiers

NCT04641585

BrAID

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Patients affected by Brugada Syndrome 1

Experimental group

Description:

Patients with spontaneous or drug-induced Brugada Syndrome 1

Treatment:

Diagnostic Test: Patients affected by Brugada Syndrome 1

Controls

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Patients affected by Brugada Syndrome 1