Echocardiography During Ajmaline Test

April 6, 2018 updated by: Esther Scheirlynck, Universitair Ziekenhuis Brussel

Dynamicity of Echocardiography During Ajmaline Test

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred for Ajmaline test, either because of symptoms or in the context of familial screening.

Description

Inclusion Criteria:

  • >17 years old
  • clinical indication for Ajmaline test

Exclusion Criteria:

  • History of right ventricular outflow tract ablation

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: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day at the time of enrollment

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Esther Scheirlynck, MD, 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 26, 2018

Primary Completion (Anticipated)

March 31, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniverstairZB

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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