A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cardiac index
研究概览
简要总结
The purpose of this study is to determine, using echocardiography, whether bi-ventricular pacing improves the contractile force by resynchronizing both ventricles, thereby improving and/or correcting the paradoxical septal movement.
Primary Hypothesis:
- Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with standard atrio-right ventricular pacing.
Secondary Hypothesis:
- Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with atrio-left ventricular pacing and right atrium pacing.
详细描述
Clinical trials done to date have focused on the efficacy of biventricular pacing (BVP) in the treatment of patients with congestive heart failure, Intraventricular conduction delay, dilated cardiomyopathies, and post cardiac surgery. However, studies done in post cardiac surgery patients are limited by their small sample size (4-22 patients with overall of 51 patients), non-randomized pacing protocol and by their inability to determine a definitive mechanism for the improved hemodynamics observed with BVP. Therefore, we propose to complete a pilot study aimed at determining both the magnitude of the hemodynamic benefit associated with BVP, if any. In addition, we will investigate changes in intra-ventricular septal motion as a possible mechanism for the previously observed changes in cardiac hemodynamics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All elective/emergent patients requiring isolated coronary artery bypass graft (CABG) at St. Michael's Hospital.
排除标准
- •Patient's age < 18 years.
- •Known atrial fibrillation.
- •Sinus tachycardia > 100 beats per minute (bpm).
- •Post-operative CI <
- •High inotrope dosage post-operation:
- •Dopamine (Intropin) if > 10 µg/kg/min.
- •Dobutamine (Dobutrex) if > 10 µg/kg/min.
- •Norepinephrine (Levophed) if > 0.1 µg/kg/min.
- •Epinephrine if > 0.1 µg/kg/min.
- •Need for intraaortic balloon pump (IABP).
- •Unable or unwilling to give informed consent.
- •Already participating in another clinical trial.
结局指标
主要结局
Cardiac index
次要结局
- Intraventricular motion