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Echocardiography During Ajmaline Test

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Unknown status
CT.gov ID
NCT03491475
Collaborator
(none)
100
Enrollment
1
Location
14.2
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

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

Arms and Interventions

Arm Intervention/Treatment
Negative Ajmaline test

No appearance of a type 1 ECG during Ajmaline test

Drug: Ajmaline test
Administration of Ajmaline
Other Names:
  • Echocardiography

    		•
    Positive Ajmaline test

    Appearance of a type 1 ECG during Ajmaline test

    Drug: Ajmaline test
    Administration of Ajmaline
    Other Names:
  • Echocardiography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Speckle tracking strain measurement [1 day at the time of enrollment]

      Cardiac function assessed by speckle tracking peak strain and peak strain dispersion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 17 years old

    • clinical indication for Ajmaline test

    Exclusion Criteria:
    • History of right ventricular outflow tract ablation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Brussel Jette Brussels Belgium 1090

    Sponsors and Collaborators

    • Universitair Ziekenhuis Brussel

    Investigators

    • Principal Investigator: Esther Scheirlynck, MD, Universitair Ziekenhuis Brussel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Esther Scheirlynck, Principal Investigator, Universitair Ziekenhuis Brussel
    ClinicalTrials.gov Identifier:
    NCT03491475
    Other Study ID Numbers:
    • UniverstairZB
    First Posted:
    Apr 9, 2018
    Last Update Posted:
    Apr 9, 2018
    Last Verified:
    Apr 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
    Keywords provided by Esther Scheirlynck, Principal Investigator, Universitair Ziekenhuis Brussel
    Ajmaline test
    Additional relevant MeSH terms:
    Brugada Syndrome
    Ajmaline

    Study Results

    No Results Posted as of Apr 9, 2018