NL-OMON37942已完成不适用
Arrhythmia Risk Stratification in a Clinical Patient Cohort and Correlation with Genotype and Environmental Modulators - EU-Trig Treat Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Clinical indication (primary and secondary prevention of SCD) for ICD implantation/ICD exchange or chronically implanted ICD
- •- Age > 18 years
- •- Written informed consent
- •- Negative pregnancy test in women of childbearing potential
- •- No participation in other clinical trials within one month before and after enrolment into the study;- Cardiac resynchronisation therapy (CRT) devices are excluded from the study (for their special effects in reversal of repolarisation remodeling) for at least 6 months after implantation, thereafter single- and dual-chamber devices are still to be preferred. Single and dual-chamber device exhange patients recruited to the invasive studies must not have RV pacing > 20% of the time.
- •- Up to 60% of all patients with coronary artery disease, with or without a history of myocardial infarction (occurrence of STEMI, NSTEMI and highest CKmax will be recorded). This will be monitored by Dr. Eva Müller from the clinical IFS institute in G*ttingen.
- •- Up to 350 patients with non-ischemic cardiomyopathies (180 dilated cardiomyopathy [DCM], 70 hypertrophic cardiomyopathy [HCM] / hypertrophic obstructive cardiomyopathy [HOCM], 20 arrhythmogenic right ventricular cardiomyopathy [ARVC], channelopathies (30 Brugada syndrome, 20 long QT syndrome, 10 catecholaminergic polymorphic ventricular tachycardia [CPVT]) or idiopathic VT/VF (n=20) with any LV ejection fraction. This will be monitored by Dr. Eva Müller from the clinical IFS institute in G*ttingen.
排除标准
- •- Unstable cardiac disease such as decompensated heart failure (NYHA class IV) or acute coronary syndrome or symptomatic arrhythmias
- •- Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery less than 3 months ago
- •- ICDs unable to deliver programmed ventricular stimulation via programmer (in the chronic ICD group)
- •- Permanent atrial fibrillation if more than 20% of all patients at a given time during the study are enrolled, this condition will be flagged by the study manager Dr. Eva Müller from the clinical IFS institute in G*ttingen which also runs the secure clinical database.
研究者
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