The Brugada Syndrome: a Follow-up Study
Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Unknown status
CT.gov ID
NCT03485508
Collaborator
(none)
150
1
99.7
1.5
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Imaging and Risk Stratification in the Brugada Syndrome: a Follow-up Study
Actual Study Start Date
:
Mar 11, 2011
Anticipated Primary Completion Date
:
Sep 1, 2018
Anticipated Study Completion Date
:
Jul 1, 2019
Outcome Measures
Primary Outcome Measures
- Composed outcome of sudden cardiac death, appropriate ICD shock and witnessed ventricular fibrillation [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.
Secondary Outcome Measures
- Syncope [6 years]
Loss of consciousness
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Brussel | Jette | Brussels | Belgium | 1090 |
Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT03485508
Other Study ID Numbers:
- 2017/253
First Posted:
Apr 2, 2018
Last Update Posted:
Apr 2, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: