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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03491475
Other study ID # UniverstairZB
Secondary ID
Status Recruiting
Phase
First received March 26, 2018
Last updated April 6, 2018
Start date March 26, 2018
Est. completion date May 31, 2019

Study information

Verified date April 2018
Source Universitair Ziekenhuis Brussel
Contact Esther Scheirlynck, MD
Phone +3228012461
Email esther.scheirlynck@uzbrussel.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study the investigators analyse echocardiographic images before and during Ajmaline test. The purpose is to know if any echocardiographic modifications are present during either negative or positive Ajmaline testing.


Description:

The diagnosis of Brugada Syndrome is made when a type 1 pattern is present on the electrocardiogram (ECG), either spontaneously or after administration of a sodium channel blocker. For pathofysiological understanding, the investigators will analyse echocardiography images before and during the administration of Ajmaline. Comparing echocardiographies before and during negative Ajmaline test, will allow the investigators to indentify the effect of Ajmaline administration on cardiac function. The comparison between images of negative and positive Ajmaline tests will expose differences related to the occurence of a type 1 ECG.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- >17 years old

- clinical indication for Ajmaline test

Exclusion Criteria:

- History of right ventricular outflow tract ablation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ajmaline test
Administration of Ajmaline

Locations

Country Name City State
Belgium UZ Brussel Jette Brussels

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speckle tracking strain measurement Cardiac function assessed by speckle tracking peak strain and peak strain dispersion 1 day at the time of enrollment
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