Division of Cardiology, Department of Internal Medicne, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- POAF lasting longer than 30 seconds during the first week after cardiac surgery
研究概览
简要总结
Post-operative atrial fibrillation (POAF) is one of the common complicaiton following cardiac surgery, occurring in approximately 20%-40% patients. Although POAF is associated with longer hospital stays, most POAF is short lived and resolves in the 2-4 days afer cardiac surgery.
However, a recent meta-analysis showed significant increases in 1,5, and 10 year mortality in POAF patients (odds ratio:1.60, 2.60, 1.51;95% confidence intervals: 1.52 to 1.68, 2.00 to 3.38, 1.43 to 1.60;P <0.0001), the combined adjusted risk of death (16 studies, n =84,295) was also significantly increased in patients with POAF (hazard ratio: 1.25;95% confidence interval: 1.2-1.3;P < 0.0001).
These data highlight the need to understand better the underlying mechanism of POAF. A latest research in Nature reported levels of circulating calcitonin (CT), which is the main risk factor for atrial fibrillation (AF). Global disruption of CT receptor signalling in mice causes atrial fibrosis and increases susceptibility to AF.
Here we will explore the relationship between CT and POAF.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of no history of atrial fibrillation/flutter;
- •Heart rate ≥50 beats/min;
- •No history of emergency cardiac surgery in our hospital;
- •Participate voluntarily and sign the informed consent, and can accept the follow-up of more than 2 years.
排除标准
- •Atrial fibrillation/flutter;
- •Left atrial diameter >5.5cm;
- •Previous cardiac surgery or emergency surgery (<12h);
- •Sick sinus node syndrome;
- •Ventricular preexcitation or preexcitation syndrome;
- •Second degree or above atrioventricular block;
- •7.Myocardial infarction occurred within 7 days;
- •Infection, sepsis, rheumatic or inflammatory diseases;
- •Abnormal liver and kidney function (three times higher than the upper limit of normal);
- •Uncontrolled hyperthyroidism, severe obstructive sleep apnea, and acute alcoholism;
- •Any ischemic events (stroke or TIA) that occurred 180 days before the participant signed the informed consent, or any known unresolved complications from previous stroke/TIA;Thrombosis;
- •Patients with other diseases requiring radiotherapy, chemotherapy and long-term hormone therapy;
- •Patients' life expectancy makes it unlikely that follow-up will be completed;
- •Participate in, or are expected to participate in, other clinical trials of any drugs, devices or biologics during the study period;
- •Patients with contraindications to dynamic electrocardiogram;
- •Patients who are unwilling or unable to fully comply with study procedures and follow-up.
结局指标
主要结局
POAF lasting longer than 30 seconds during the first week after cardiac surgery
时间窗: 2 years after cardiac surgery
The incidence of atrial fibrillation lasting longer than 30 seconds during the first week after cardiac surgery
次要结局
- Levels of serum procalcitonin(2 years after cardiac surgery)
- Levels of serum hsCRP(2 years after cardiac surgery)
- Levels of serum cytokines(IL-1β，IL-2R，IL-6，IL-8，IL-10，TNF-α)(2 years after cardiac surgery)
- The hospitalization days(2 years after cardiac surgery)
- Ventricular rate of the atrial fibrillation(2 years after cardiac surgery)
- Levels of serum calcitonin(2 years after cardiac surgery)
- Atrial fibrillation burden after cardiac surgery(lidan2014@tjh.tjmu.edu.cn)
研究者
Li Ni
Division of Cardiology, Department of Internal Medicne
Tongji Hospital