Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ICM group: Atrial fibrillation
研究概览
简要总结
Myocardial infarction with non-obstructive coronary arteries (MINOCA) (i.e.<50% stenoses) on coronary angiography) is an underappreciated clinical entity concerning 5-6% of patients with acute myocardial infarction. Approximately 50% of these patients remain without appropriate diagnosis and treatment.
The MINOCA study aims at systematically assessing the frequency of underlying pathologies of MINOCA and outcomes with a multidisciplinary etiologic work-up and follow-up of 5 years including, for the first time, an implantable cardiac monitor (ICM) to assess the frequency of atrial fibrillation as underlying cause for MINOCA.
详细描述
Approximately 5-6% of patients with acute myocardial infarction (AMI) have myocardial infarction with non-obstructive coronary arteries (MINOCA) (i.e.<50% stenoses) on coronary angiography and up to 50% of these patients remain without appropriate diagnosis and treatment. A multidisciplinary etiologic work-up of MINOCA has recently been proposed by international consensus documents. The present study aims for a structured scientific data collection from a full guideline-based work-up after MINOCA and follow-up of 5 years to assess clinical outcomes.
Untreated atrial fibrillation is a potentially neglected underlying cause of MINOCA. As implantable cardiac monitors (ICM) can detect atrial fibrillation with high accuracy, the aim of this study is, for the first time, to assess the occurrence of first diagnosed atrial fibrillation with the use of ICM in patients with MINOCA.
To allow for an all-comers data collection, patients with contraindication(s) to ICM implantation will be enrolled into the non-ICM group to assess the frequency of underlying causes of MINOCA and clinical outcomes throughout 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
ICM group: Atrial fibrillation
时间窗: 1 year
The occurrence of first diagnosed atrial fibrillation in patients with MINOCA according to ICM
Non-ICM group: Frequency of underlying causes of MINOCA
时间窗: 1 year
The frequency of underlying causes of MINOCA (i.e. plaque rupture, plaque erosion, coronary thrombus, coronary dissection, eruptive calcific nodule, coronary spasm (including microvascular dysfunction), coronary thromboembolism due to intra- or extracardiac sources of thrombi (including thromboembolism in the context of a persistent foramen ovale (PFO)), atrial fibrillation according to 3 7-day-Holter-ECGs, other sources of coronary embolism (e.g. vegetations, complex aortic plaques), and arterial thrombophilia
次要结局
- Both groups: Clinical outcomes(5 years)
- ICM group: Frequency of non atrial fibrillation related etiologies of MINOCA(1 year)
- ICM group: Other brady- or tachyarrhythmias(~2 years (battery end of life or explantation of ICM))
- ICM group: Time to first diagnosed atrial fibrillation(~2 years (battery end of life or explantation of ICM))
- ICM group: Atrial fibrillation burden(~2 years (battery end of life or explantation of ICM))
- ICM group: First diagnosis of atrial fibrillation, stroke or death(1 year)
- ICM group: Predictive value of CMR parameters for atrial fibrillation(~2 years (battery end of life or explantation of ICM))
- ICM group: Time to different durations of first diagnosed atrial fibrillation(~2 years (battery end of life or explantation of ICM))