Clinical trial NCT02933437: The Response To Ajmaline Provocation in Healthy Subjects
Official title: An Observational Study Into the Variety of Electrocardiographic Responses to an Ajmaline Provocation in a Healthy Subjects. What Are the Genetic and Structural Variations Dictating This Response ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brugada Syndrome
Sudden Death
Keywords: Brugada syndrome
SCN5A
SCN10A
Ajmaline
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The qualitative and quantitative effects of ajmaline provocation on parameters of cardiac conduction in healthy subjects using the surface electrocardiogram
timeFrame: ten minutes
Secondary outcomes:
measure: The influence of normal variations in right ventricular outflow tract dimensions on the electrocardiographic response to ajmaline provocation in healthy subjects using cardiac magnetic resonance imaging.
timeFrame: intraoperative
measure: Genotype linkage analysis of the electrocardiographic response to ajmaline provocation in healthy subjects using candidate gene and gene wide association studies.
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's University Of London
Study officials:
affiliation: St George's, University of London
name: Elijah Behr, MD
role: PRINCIPAL_INVESTIGATOR
References: