NCT03491475

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

March 26, 2018

Last Update Submit

April 6, 2018

Conditions

Brugada Syndrome

Keywords

Ajmaline test

Outcome Measures

Primary Outcomes (1)

  • Speckle tracking strain measurement

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

    1 day at the time of enrollment

Study Arms (2)

Negative Ajmaline test

No appearance of a type 1 ECG during Ajmaline test

Drug: Ajmaline test

Positive Ajmaline test

Appearance of a type 1 ECG during Ajmaline test

Drug: Ajmaline test

Interventions

Ajmaline testDRUG

Administration of Ajmaline

Also known as: Echocardiography
Negative Ajmaline testPositive Ajmaline test

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \>17 years old
  • clinical indication for Ajmaline test

You may not qualify if:

  • History of right ventricular outflow tract ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Brugada Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Esther Scheirlynck, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Scheirlynck, MD

CONTACT

+3228012461esther.scheirlynck@uzbrussel.be

Ingrid Lemoine

CONTACT

ingrid.lemoine@uzbrussel.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 9, 2018

Study Start

March 26, 2018

Primary Completion

March 31, 2019

Study Completion

May 31, 2019

Last Updated

April 9, 2018

Record last verified: 2018-04

Locations

BE(1)