Brugada SyndromeNCT03491475
Echocardiography During Ajmaline Test
An observational study of Brugada Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brugada Syndrome
- What is being tested?
- Ajmaline test
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Mar 2018to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for Ajmaline test, either because of symptoms or in the context of familial screening.
Who may be able to join
- >17 years old
- clinical indication for Ajmaline test
Who cannot join
- History of right ventricular outflow tract ablation
Trial locations and contacts
1 site in 1 country.
Ingrid Lemoine contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1090
Catherine De Greef, catherine.degreef@uzbrussel.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Brugada Syndrome
- Being tested
- Ajmaline test
- Keywords
- Ajmaline test
- Medical subject headings
- Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ajmaline testDrug
Also called Echocardiography
Administration of Ajmaline
| Study group | Role | What they receive |
|---|---|---|
| Negative Ajmaline test | No appearance of a type 1 ECG during Ajmaline test Receives: Drug: Ajmaline test | |
| Positive Ajmaline test | Appearance of a type 1 ECG during Ajmaline test Receives: Drug: Ajmaline test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speckle tracking strain measurement
Cardiac function assessed by speckle tracking peak strain and peak strain dispersion
Measured: 1 day at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start26 Mar 2018
- Primary completion31 Mar 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brugada SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Scheirlynck, Universitair Ziekenhuis Brussel
- Investigators
- Esther Scheirlynck, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491475
- Sponsor's protocol ID
- UniverstairZB
- Status last verified
- Apr 2018
- First submitted
- 26 Mar 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamicity of Echocardiography During Ajmaline Test
- ClinicalTrials.gov ID
- NCT03491475
- Acronym / sponsor ID
- UniverstairZB
- Conditions
- Brugada Syndrome
- Keywords
- Ajmaline test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Ajmaline test | – | Drug: Ajmaline testNo appearance of a type 1 ECG during Ajmaline test |
| Positive Ajmaline test | – | Drug: Ajmaline testAppearance of a type 1 ECG during Ajmaline test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for Ajmaline test, either because of symptoms or in the context of familial screening.
Key inclusion criteria (2 listed)
- >17 years old
- clinical indication for Ajmaline test
Key exclusion criteria (1 listed)
- History of right ventricular outflow tract ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ajmaline testAlso: EchocardiographyAdministration of Ajmaline | Drug | Negative Ajmaline test, Positive Ajmaline test |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Lemoine contact
Esther Scheirlynck, MD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Scheirlynck, MD (+3228012461, esther.scheirlynck@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speckle tracking strain measurement (time frame: 1 day at the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.