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Echocardiography During Ajmaline Test

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ClinicalTrials.gov Identifier: NCT03491475
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Esther Scheirlynck, Universitair Ziekenhuis Brussel

Brief 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.

Condition or disease Intervention/treatment
Brugada Syndrome Drug: Ajmaline test

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Dynamicity of Echocardiography During Ajmaline Test
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Negative Ajmaline test
No appearance of a type 1 ECG during Ajmaline test
Drug: Ajmaline test
Administration of Ajmaline
Other Name: Echocardiography

Positive Ajmaline test
Appearance of a type 1 ECG during Ajmaline test
Drug: Ajmaline test
Administration of Ajmaline
Other Name: Echocardiography




Primary Outcome Measures :
  1. Speckle tracking strain measurement [ Time Frame: 1 day at the time of enrollment ]
    Cardiac function assessed by speckle tracking peak strain and peak strain dispersion



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for Ajmaline test, either because of symptoms or in the context of familial screening.
Criteria

Inclusion Criteria:

  • >17 years old
  • clinical indication for Ajmaline test

Exclusion Criteria:

  • History of right ventricular outflow tract ablation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491475


Contacts
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Contact: Esther Scheirlynck, MD +3228012461 esther.scheirlynck@uzbrussel.be
Contact: Ingrid Lemoine ingrid.lemoine@uzbrussel.be

Locations
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Belgium
UZ Brussel Recruiting
Jette, Brussels, Belgium, 1090
Contact: Catherine De Greef       catherine.degreef@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Esther Scheirlynck, MD Universitair Ziekenhuis Brussel

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Responsible Party: Esther Scheirlynck, Principal Investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03491475     History of Changes
Other Study ID Numbers: UniverstairZB
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esther Scheirlynck, Universitair Ziekenhuis Brussel:
Ajmaline test
Additional relevant MeSH terms:
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Brugada Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn
Ajmaline
Lorajmine
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action