The Brugada Syndrome: a Follow-up Study

March 26, 2018 updated by: Universitair Ziekenhuis Brussel

Imaging and Risk Stratification in the Brugada Syndrome: a Follow-up Study

Although for many years the Brugada syndrome has been labelled as a purely electrical disease in the structurally normal heart, the evolution of imaging techniques has enabled the discovery of subtle morphofunctional alterations in some of the Brugada syndrome patients. We will use new echocardiographic techniques to assess cardiac function in these patients and new parameters will be evaluated for their prognostic value as risk stratificators.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Brugada syndrome patients visiting the UZ Brussel for diagnosis or follow-up.

Description

Inclusion Criteria:

  • 18 years or older
  • Diagnosis of Brugada syndrome

Exclusion Criteria:

  • history of pericarditis, ischemic heart disease, cardiomyopathy of any origin, structural heart disease, or any other channelopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composed outcome of sudden cardiac death, appropriate ICD shock and witnessed ventricular fibrillation
Time Frame: 6 years
Sudden cardiac death is death occuring within 24 hours after being seen in a healthy status or within 1 hour after initiation of symptoms.
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Syncope
Time Frame: 6 years
Loss of consciousness
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2011

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

March 26, 2018

First Posted (Actual)

April 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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