The Response To Ajmaline Provocation in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-22

Study Completion Date

2019-12-31

Brief Summary

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Standard, high lead and sodium channel provoked electrocardiograms of a healthy volunteers will be performed to observe the various ECG changes. Participants will the undergo detailed imaging with cardiac magnetic resonance imaging and deep genotyping to identify structural or genetic variants which might dictate the electrocardiographic patterns at rest and with sodium channel provocation.

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Detailed Description

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The investigators will recruit healthy subjects without a history of cardiac symptoms or a family history of sudden death or premature arrhythmogenic cardiac disease. Participants will undergo electrocardiographic phenotype assessment with standard and high lead electrocardiogram and sodium channel provocation. Detailed cardiac structural examination will be performed with cardiac magnetic resonance imaging to look for any variation in mainly right ventricular outflow tract structure and myocardial architecture. Participants will also undergo targeted genomic sequencing to look for variations in genes encoding for cardiac sodium channel.

Conditions

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Brugada Syndrome Sudden Death

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Once screened by the investigators, the participants will undergo ajmaline provocation, cardiac magnetic resonance imaging and genotype evaluation

Group Type EXPERIMENTAL

Ajmaline

Intervention Type DRUG

Ajmaline 1milligram/kilogram max dose as bolus intravenous over 10 minutes with continuous ECG monitoring

Interventions

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Ajmaline

Ajmaline 1milligram/kilogram max dose as bolus intravenous over 10 minutes with continuous ECG monitoring

Intervention Type DRUG

Other Intervention Names

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GILURYTMAL

Eligibility Criteria

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Inclusion Criteria

* Asymptomatic healthy Volunteers

Exclusion Criteria

* • Any prior cardiovascular illness

* Previous cardiac symptoms.
* History of unexplained syncope
* Any family history of proven sudden cardiac death or unexplained sudden death either in adulthood or infancy.
* Those unable to provide a two generation family history
* Abnormal resting ECG
* Any contraindications to cardiac magnetic resonance imaging
* Pregnant or breastfeeding women
* Intercurrent use of any medication known to be contraindicated in Brugada Syndrome

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes