EUCTR2016-004277-41-GB进行中（未招募）1 期
An observational study into the variety of electrocardiographic responses to an ajmaline Provocation in healthy subjects. What are the genetic and structural variations dictating this response ? - The Response To Ajmaline Provocation in Healthy Subjects
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Asymptomatic healthy individuals
- •Aged 18-65
- •Kidney function = 30ml/min/1.73m2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •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
- •Abnormal screening cardiac ultrasound
- •Any contraindications to cardiac magnetic resonance imaging participant has cardiac pacemaker; recent surgery; vascular clips; metal implants or joint replacements; have had metal fragments in their eyes; has ever worked on a lathe; has shrapnel from a war injury
- •Known allergy e.g. seafood, hayfever, hives
- •Pregnant or breastfeeding women
- •Male or pre-menopausal female participants of child-bearing potential* unwilling to use an effective method of birth control (either hormonal in the form of the contraceptive pill or barrier method of birth control accompanied by the use of a proprietary spermicidal foam/gel or film ; or agreement of true abstinence (i.e. withdrawal, calendar, ovulation, symptothermal and post ovulation are not acceptable methods) from time consent is signed until 6 weeks after the last dose of IMP
- •Enrolled on another CTIMP study
- •Intercurrent use of any medication known to be contraindicated in Brugada Syndrome
- •Any contraindication to ajmaline Provocation as detailed in the approved St George’s Hospital clinical ajmaline protocol.
- •*Subjects are only considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
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