Subtle Ultrasound Atrial Anomalies Predicts the Early Diagnosis of Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Patients With Cryptogenic Stroke. A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Detection atrial fibrilation at follow-up
研究概览
简要总结
Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF.
The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.
详细描述
Introduction
Cryptogenic stroke (CS) is a stroke in which etiology cannot be determined after a comprehensive evaluation and it is the cause of about 30% of admissions to a stroke unit. In these cases single antiplatelet therapy is recommended as a long term treatment. However, silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of episodes, and it´s recognition merits urgency since carries to oral anticoagulation (OAC) and antiplatelet therapy cessation. According to guidelines, in order to detect PAF we need to monitor the patient´s ECG for at least 48h, although the longer the monitoring is, the better the diagnostic yield.
Previous research showed controversial results regarding the use of implantable cardiac monitors (ICM) in such patients when the ICM had been implanted late after the CS. On the other hand, studies with an early implant demonstrated a clear benefit in the diagnostic yield. To date, the strategy to search actively for PAF in patients with CS is still not well established, and even when internal loop recorders (ILR) are our best option to recognize paroxysmal arrhythmic events, guidelines are not clear about the cases in which they might be indicated. Some markers, such as age, cardiovascular risk factors, blood biomarkers or cardiac ultrasound characteristics have been related to a higher silent PAF detection. Recent data points at the use of left atrium atrial strain (LAS) to select the patients more prone to suffer from silent PAF.
It remains to be defined the usefulness of ILR implanted early after the CS in order to diagnose the presence of silent PAF, and the roll or ACS in such patients in order to predict those being at higher risk.
Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023
- •Age between 50 and 89 years;
- •Undetermined origin at hospital admission according to the SSS-TOAST criteria (2):
- •Absence of major structural heart disease by cardiac ultrasound (normal global and segmental left ventricle contraction, absence of valvular/rheumatic disease, absence of intracardiac shunts)
- •Absence of AF during 48h ECG-monitoring
- •Absence of major anomalies in the supra-aortic trunks ultrasound.
排除标准
- •Patients with a history of hemorrhagic stroke;
- •Presence with prior atrial fibrillation or atrial flutter;
- •Permanent contraindication or indication for OAC for other reasons;
- •Recent (<1 month) major surgery or cardiac events;
- •Presence of severe cardiac abnormalities;
- •Patients with life expectancy <1 year or severe stroke (modified Rankin Scale > 4).
结局指标
主要结局
Detection atrial fibrilation at follow-up
时间窗: Up to 2 years follow-up (ICM and standard care practice)
defined by the presence of a confirmatory 12-leads ECG, or a registration lasting more than 30 seconds in, either the 72h-Holter-Monitoring, or in the ICM recording. In case of AF detection OAC was initiated immediately.
次要结局
- Maximum Systolic Global Longitudinal Strain (PALs)(Before Day 3 since the Criptogenic Stroke)
- Atrial Contraction Strain (PACs)(Before Day 3 since the Criptogenic Stroke)
- Atrial Ejection Fraction(Before Day 3 since the Criptogenic Stroke)
- LA indexed volume(Before Day 3 since the Criptogenic Stroke)
- stroke recurrences(Up to 2 years follow-up (ICM and standard care practice))
研究者
Ermengol Vallès
Head of arrhythmias
Parc de Salut Mar