Development and Validation of Risk Prediction Model for Severe Ventricular Arrhythmias in Patients With Mitral Valve Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Severe Ventricular Arrhythmias
研究概览
简要总结
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.
详细描述
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.
The aim of this study is to develop and validate a risk prediction model for severe ventricular arrhythmias in patients with AMVP, with the goal of improving individualized risk stratification and identying patients who may warrant consideration for ICD therapy.
This is a retrospective, multicenter longitudinal cohort study of patients with mitral valve prolapse and ventricular arrhythmias. Baseline characteristics are defined based on the clinical status at the index event and during the subsequent six months. Clinical events occurring six months or more after the index event are considered follow-up events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MVP according to the ESC definition AND
- •Arrhythmic burden of:
- •A total PVC burden ≥ 0,5 % per day OR
- •Documentation of NSVT on any modality OR
- •More severe ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest) that occurred >1 month after the beginning of follow up.
- •Follow up >6 months
排除标准
- •1. VT/VF as the initial presentation without prior cardiac evaluation (ECG, echo, Holter)
- •History of myocardial infarction
- •Obstructive coronary diseases - ≥50 % stenosis that was not treated
- •History of coronary artery bypass surgery
- •Significant valve disease other than MVP - rheumatic heart disease, severe aortic stenosis
- •LGE suggestive of probable myocarditis as the etiology.
- •Primary inherited arrhythmia - Brugada syndrome, short QT, long QT, CPVT
- •Carrier of disease causing mutation known to be associated with arrhythmia even when phenotype is negative (e.g. Lamin A/C)
- •Sustained ventricular arrhythmia clearly caused by a reversable cause
研究组 & 干预措施
Patients with Mitral Valve Prolapse and Ventricular Arrhythmias
Patients with mitral valve prolapse and ventricular arrhythmias will be included in the study cohort. Clinical, echocardiographic, arrhythmic and other cardiac imaging variables will be evaluated in relation to the occurence of life-threatening ventricular arrhythmias. No study-specific intervention is performed.
干预措施: Risk prediction model (Other)
结局指标
主要结局
Severe Ventricular Arrhythmias
时间窗: From >6 months after baseline until the end of available follow-up, minimum follow-up 6 months
Occurence of severe ventricular arrhythmias, defined as ventricullar fibrillation, sustained ventricular tachycardia, aborted cardiac arrest or appropriate implantable cardioverter-defibrillator (ICD) therapy, occuring more than 1 month after baseline.
次要结局
未报告次要终点
研究者
Kristina Hermann Haugaa
Professor, MD, PhD
Oslo University Hospital