NL-OMON56447招募中不适用
oninvasive electrocardiographic imaging for individuals at risk for apparently idiopathic ventricular fibrillation - VIGILANCE
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 550 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must be >= 18
- •years old and meet one of the following criteria:- All unexplained polymorphic
- •VT or VF survivors in whom known structural myocardial, respiratory, metabolic
- •and toxicological causes have been excluded through clinical evaluation*,
- •with/without a genetic mutation.
- •NB. If results of a diagnostic tests show minor abnormalities but insufficient
- •for a specific diagnosis, this is no exclusion criterion.
- •- Selected family members of these patients*
- •- Control subjects with structurally normal hearts with a clinical indication
- •for a cardiac CT scan, as already approved in METC protocol NL32128.068.11 (ABR
- •number 32128). *All 1st and 2nd degree family members being in contact with the
- •cardiologist/treating physician as part of cascade screening will be contacted.
- •Family members must be in adequate health to be able to travel to the hospital
- •for research purposes. 3rd degree family members in contact with the
- •cardiologist/treating physician can also be contacted if at least one of the
- •following criteria is met:
- •The family member has the same genetic mutation as index patient, or;
- •The family member has demonstrated ventricular arrhythmias, or;
- •The clinician has a very strong suspicion of ventricular arrhythmias in the
- •family member.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:- A known strong reaction against electrode
- •attachment or contrast agent.
- •- Any serious medical condition, which in the opinion of the investigator, may
- •adversely affect the safety and/or effectiveness of the participant or the
- •- Pregnancy, nursing or planning to be pregnant.
- •- Subject has an estimated glomerular filtration rate (eGFR) of
- •<30mL/min/1.73m2, using the MDRD calculation.
- •- Unability to give informed consent.
- •- Family members of a patients with idiopathic unexplained polymorphic VT/VF ,
- •who have severe cardiac abnormalities and/or disease not related to the
- •symptoms or phenotype of the index patients and which may have a negative
- •influence on results of ECGI according to local investigators.
研究者
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