Echocardiography During Ajmaline Test | NCT03491475

Studies
Echocardiography During Ajmaline Test

NCT03491475

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Apr 9, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Brugada Syndrome

Interventions

Ajmaline test

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2018Actual

Primary Completion Date

Mar 31, 2019Estimated

Completion Date

May 31, 2019Estimated

First Submitted Date

Mar 26, 2018

First Submission Date that Met QC Criteria

Apr 6, 2018

First Posted Date

Apr 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2018

Last Update Posted Date

Apr 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Esther Scheirlynck, Principal Investigator, Universitair Ziekenhuis BrusselPrincipal Investigator

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ajmaline test	Drug	Administration of Ajmaline	Negative Ajmaline test Positive Ajmaline test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Speckle tracking strain measurement	Cardiac function assessed by speckle tracking peak strain and peak strain dispersion	1 day at the time of enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>17 years old
clinical indication for Ajmaline test

Exclusion Criteria:

History of right ventricular outflow tract ablation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Esther Scheirlynck, MD	Contact	+3228012461		esther.scheirlynck@uzbrussel.be
Ingrid Lemoine	Contact			ingrid.lemoine@uzbrussel.be

Overall Officials

Name	Affiliation	Role
Esther Scheirlynck, MD	Universitair Ziekenhuis Brussel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Brussel	Recruiting	Jette	Brussels Capital	1090	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053840	Brugada Syndrome

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

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Browse Branches

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