Safety and Feasibility Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study will evaluate the application of hAM at the time of cardiac surgery to decrease inflammation and the subsequent substrate to reduce incidence of post-operative atrial fibrillation. Patients will randomized 1:1 to receive either hAM application or standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients undergoing primary elective CABG at the University of Utah Hospital
- •Ability to provided informed consent and follow-up with protocol procedures
排除标准
- •Patients in AF at the time of surgery
- •Prior history of sternotomy
- •Prior history of pericarditis
- •Currently on aggressive antiarrhythmic therapy (does not include beta blockers)
- •Patients with an implantable cardiac device (pacemaker, ICD, CRT-D)
- •Ejection fraction <45%
研究组 & 干预措施
Control
Randomized
干预措施: Human Amniotic Membrane (Biological)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 1 month
The AM applied epicardially will be assessed for signs of hyperacute rejection i.e. membrane changing color; cardiac tamponade or constriction assessed by echocardiogram and transmission of infectious diseases. The incidence of adverse events (AEs) will be reported as percentages, with two-sided 95% confidence intervals. Statistical comparisons of AEs between the AM treatment and the control group will be made using a chi-square, or Fisher's exact test, as appropriate (based on the minimum expected cell frequencies).
Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls
时间窗: 1 month
The number of patients with Post Op Atrial Fibrillation will be compared between the treatment and control group using mobile telemetry. This comparison will be analyzed using chi-square or Fisher's exact test as appropriate.
proBNP (Serum) Between Groups at Time of Surgery
时间窗: Surgery
Comparison of serum levels of proBNP between groups at the time of surgery (baseline).
C-reactive Protein (Serum) Between Groups at Time of Surgery
时间窗: Surgery
Comparison of serum levels of CRP between groups at the time of surgery (baseline).
Interleukin-6 (Serum) Between Groups at Time of Surgery
时间窗: Surgery
Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline).
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery
时间窗: Surgery
Comparison of serum levels of TNFa between groups at the time of surgery (baseline).
proBNP (Serum) Between Groups at 24 Hours Post-op
时间窗: 24 hours
Comparison of serum proBNP levels between groups at 24 hours post-op
C-reactive Protein (Serum) Between Groups at 24-hours Post-op
时间窗: 24 hours
Comparison of serum measurements of CRP between groups at 24 hours post-op
Interleukin-6 (Serum) Between Groups at 24-hours Post-op
时间窗: 24 hours
Comparison of IL-6 serum levels between groups at 24 hours post-op
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op
时间窗: 24 hours
Comparison of serum levels of TNFa between groups at 24 hours post-op
proBNP (Serum) Between Groups at 48 Hours Post-op
时间窗: 48 hours
Comparison of serum levels of proBNP between groups at 48 hours post-op
C-reactive Protein (Serum) Between Groups at 48 Hours Post-op
时间窗: 48 hours
Comparison of serum CRP levels between groups at 48 hours post-op
Interleukin-6 (Serum) Between Groups at 48 Hours Post-op
时间窗: 48 hours
Comparison of IL-6 serum results between groups at 48 hours post-op
Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op
时间窗: 48 hours
Comparison of serum TNFa levels between groups at 48 hours post-op
proBNP (Serum) Between Groups at 72 Hours Post-op
时间窗: 72 hours
Comparison of serum levels of proBNP between groups at 72 hour post-op
CRP (Serum) Between Groups at 72 Hours Post-op
时间窗: 72 hours
Comparison of serum levels of CRP between groups at 72 hour post-op
Interleukin-6 (Serum) Between Groups at 72 Hours Post-op
时间窗: 72 hours
Comparison of IL-6 serum levels between groups at 72 hours post-op
TNFa (Serum) Between Groups at 72 Hours Post-op
时间窗: 72 hours
Comparison of TNFa serum levels between groups at 72 hours post-op
proBNP (Serum) Between Groups at Follow-up
时间窗: 1 month
Comparison of serum levels of proBNP between groups at follow-up
CRP (Serum) Between Groups at Follow-Up
时间窗: 1 month
Comparison of serum CRP levels between groups at follow-up
Interleukin-6 (Serum) Between Groups at Follow-up
时间窗: 1 month
Comparison of IL-6 serum levels between groups at follow-up
TNFa (Serum) Between Groups at Follow-up
时间窗: 1 month
Comparison of TNFa serum levels between groups at follow-up
proBNP (Pericardial Fluid) Between Groups at Time of Surgery
时间窗: Surgery
Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline)
C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery
时间窗: Surgery
Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline).
Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery
时间窗: Surgery
Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline).
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery
时间窗: Surgery
Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline).
proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op
时间窗: 24 hours
Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op
C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op
时间窗: 24 hours
Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op
Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op
时间窗: 24 hours
Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op
时间窗: 24 hours
Comparison of TNFa in pericardial fluid between groups at 24 hours post-op.
proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op
时间窗: 48 hours
Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op.
C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op
时间窗: 48 hours
Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op
Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op
时间窗: 48 hours
Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op
时间窗: 48 hours
Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op
proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op
时间窗: 72 hours
Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op
C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op
时间窗: 72 hours
Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op
Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op
时间窗: 72 hours
Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op
时间窗: 72 hours
Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op
次要结局
未报告次要终点
研究者
Vikas Sharma
Associate Professor
University of Utah