Electrical Cardioversion of Recent Onset Atrial Fibrillation - a Study of Silent Thromboembolic Events, Reverse Atrial Electrical and Functional Remodeling Including Inflammatory, Neurohormonal and Thromboembolic Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Percentage of patients with new cerebral ischemic events detected by nuclear Magnetic Resonance Imaging (MRI) of the brain after direct current electrical cardioversion (DCC), summing up those detected within 24 hours and those at 7 - 10 days after DCC.
研究概览
简要总结
The purpose of this study is to study the effects of transthoracic electrical cardioversion for restoration of sinus rhythm in patients who present with recent onset atrial fibrillation, with regard to new silent cerebral thrombo-embolic lesions and cognitive function, as well as electrical and functional/structural reverse remodelling, and its effects on inflammatory changes / specific cardiac biomarkers, vasoactive peptides, coagulation activity, and active fibrinolysis.
详细描述
Working plan This study will give information about the incidence of silent cerebral thrombo-embolic events in patients with recent onset AF, a population which is expected to consist mostly of paroxysmal AF patients.
Patients with atrial fibrillation (AF) duration less than 48 hours and fulfilling inclusion and not exclusion criteria will be included in the study by a cardiologist on the day of cardioversion, and study nurse will be notified to plan for the investigations. The patient will undergo clinical examination, clinical history will be taken and blood sampling. Once 12 lead ECG, echocardiography, questionnaires, telemetry and MR have been done the patient will be electrically cardioverted After the cardioversion the patient will be subject to echocardiography of the heart again, blood-sampling, 12 lead ECG, and MR brain. The patient is discharged but will be studied by echocardiography of the heart and MR brain again on day 7 - 10. Thereafter the patient will be followed for 30 days - see flowchart.
The day of cardioversion is defined as Day 0.
3.1. ASSESSMENT OF REMODELING/REVERSE REMODELING 3.1.1. Electrical remodeling Standard 12-Lead electrocardiography (ECG) at every health care visit. (Day -1, Day 0 before and immediately after DCC, Day 0 at discharge, Day 7-10 and 30). Recorded with automatic analysis of intervals, Paper speed 50 mm/sec.
O Data to be collected: Rhythm, heart rate, P wave duration and amplitude.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial fibrillation of recent onset (less than 48 hours) ongoing at time for baseline MRI.
- •Age: 18-75 years
排除标准
- •Recent (less than 3 months) cardioversion of AF or atrial flutter
- •Previous clinical cerebrovascular event
- •Congestive heart failure New York Heart Association (NYHA) function class III and IV
- •Previously documented moderate or severely decreased left ventricular ejection fraction (LVEF less than 35%)
- •Previously documented marked mitral regurgitation or stenosis
- •Atrial flutter, atypical atrial flutter or intra-atrial re-entry tachycardia
- •Contraindications to electrical cardioversion
- •Permanent implanted cardiac device (event recorders accepted)
- •Contraindication to nuclear magnetic resonance imaging (MRI) - see separate list addendum
- •Known coagulation defects or spontaneous INR or activated partial thromboplastin time (APTT) levels at therapeutic levels
- •Current Vitamin K antagonists (VKA) or Novel Oral Anticoagulation (NOAC) treatment
- •Spontaneous conversion to sinus rhythm prior to first MRI
结局指标
主要结局
Percentage of patients with new cerebral ischemic events detected by nuclear Magnetic Resonance Imaging (MRI) of the brain after direct current electrical cardioversion (DCC), summing up those detected within 24 hours and those at 7 - 10 days after DCC.
时间窗: Immediately after cardioversion of atrial fibrillation up to 10 days
New cerebral ischemic events detected by MRI directly after cardioversion and after 7 - 10 Days, at which MRI are performed.
次要结局
- Sinus node recovery(Day 0, after DC cardioversion)
- Cognitive function as assessed by Mini-mental test(Day 0 prior to cardioversion, Day 7-10, Day 30 and when clinically evident cerebrovascular event)
- Cardiac bio-markers(Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3).)
- Number of new cerebral ischemic events detected on MRI after electrical cardioversion, summing up those detected within 24 hours and those at 7 - 10 days after DCC(Before and directly after cardioversion, and after 7-10 days.)
- Cerebral damage(Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3).)
- Echocardiographic left ventricular parameters(Day before and immediately after Cardioversion, Day 0 at discharge, Day 7-10 and 30 after Cardioversion.)
- Atrial fibrillation relapse(Through study completion, an average of 30 days)
- Active fibrinolysis markers.(Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3).)
- Echocardiographic Atrial parameters(Day before and immediately after Cardioversion, Day 0 at discharge, Day 7-10 and 30 after Cardioversion.)
- Inflammatory markers(Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3).)
- Atrial electrical remodeling parameters.(Day before and immediately after DCC, Day 0 at discharge, Day 7-10 and 30 after DCC.)
- Cognitive function as assessed by Trail Making Test(Day 0 prior to cardioversion, Day 7-10, Day 30 and when clinically evident cerebrovascular event)
- Coagulation activity(Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3).)
研究者
Carina Blomstrom Lundqvist
professor, senior consultant
Uppsala University Hospital