TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
To compare of atrial arrhythmia incidence in patients with coronary artery disease and atrial fibrillation history, undergoing either coronary artery bypass grafting plus temporary spinal cord stimulation or coronary artery bypass grafting alone
详细描述
The study includes 60 patients. Patients are randomized into 2 groups: coronary artery bypass grafting plus b-blocker treatment (according to guidelines; group I) and coronary artery bypass grafting plus b-blocker treatment (according to guidelines) plus temporary spinal cord stimulation (group 2). Temporary spinal cord stimulation is performed for 3 days before surgery and 7 days after coronary artery bypass grafting. Continuous ECG during intensive care unit stay, daily ECG and 24-h Holter monitor recordings at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit until 30 days after coronary artery bypass grafting. Rhythm status and clinical outcome assessment at 12 month follow up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years;
- •indications for coronary artery bypass grafting according to guidelines;
- •pre-operative history of paroxysmal atrial fibrillation;
- •absent of contraindications for spinal cord stimulation;
- •signed inform consent.
排除标准
- •previous heart surgery or atrial fibrillation ablation procedure;
- •emergency coronary artery bypass grafting;
- •left ventricle ejection fraction <35%;
- •unstable angina or heart failure;
- •persistent atrial fibrillation or atrial fibrillation at the time of screening;
- •planned Maze procedure or pulmonary vein isolation;
- •use of class I or III antiarrhythmic drugs within 5 elimination half-lives of the drug;
- •need for concomitant valve surgery;
- •Inability to control the device for spinal cord stimulation;
- •coagulopathy, immunosuppression, or other condition associated with an unacceptable surgical risk for spinal cord stimulation;
- •Need for therapeutic diathermy in the area of leads placement;
- •Need for pacemaker/ICD/CRT-D implantation;
- •unwillingness to participate.
研究组 & 干预措施
CABG + b-blockers
Standart coronary artery bypass grafting is performed with b-blockers treatment. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.
干预措施: Coronary artery bypass grafting (Procedure)
CABG + b-blockers
Standart coronary artery bypass grafting is performed with b-blockers treatment. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.
干预措施: B-blockers (Drug)
CABG + b-blockers + temporary SCS
Before coronary artery bypass grafting in the experimental group, 3 days of temporary spinal cord stimulation is performed than device turned off and coronary artery bypass grafting procedure is made. The device for spinal cord is turned on in intensive care unit for 7 days. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.
干预措施: Temporary spinal cord stimulation (Device)
CABG + b-blockers + temporary SCS
Before coronary artery bypass grafting in the experimental group, 3 days of temporary spinal cord stimulation is performed than device turned off and coronary artery bypass grafting procedure is made. The device for spinal cord is turned on in intensive care unit for 7 days. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.
干预措施: Coronary artery bypass grafting (Procedure)
CABG + b-blockers + temporary SCS
Before coronary artery bypass grafting in the experimental group, 3 days of temporary spinal cord stimulation is performed than device turned off and coronary artery bypass grafting procedure is made. The device for spinal cord is turned on in intensive care unit for 7 days. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.
干预措施: B-blockers (Drug)
结局指标
主要结局
Occurrence of adverse events
时间窗: 30 days
MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury
Occurrence of atrial tachyarrhythmias
时间窗: 30 days
Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec during 30 days after surgery
Occurrence of tachyarrhythmias
时间窗: 12 months
Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec 30 days after surgery
次要结局
- Hemodynamic parameter - Heart rate(30 days)
- Hemodynamic parameter - Cardiac index(30 days)
- Renal-replacement therapy(30 days)
- Acute pain assessment(30 days)
- Inotropic score(30 days)
- Duration of mechanical ventilation(30 days)
- Duration of intensive care unit stay(30 days)
- Marker of myocardial injury - high-sensitive Troponin I(30 days)
- Marker of myocardial injury - CK-MB(30 days)
- Marker of kidney injury - Creatinine(30 days)
- Hemodynamic parameter - Blood pressure(30 days)
- Hemodynamic parameter - Vascular resistance(30 days)