Clinical trial NCT04130061: Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation
Official title: Safety and Feasibility Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation After Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Atrial Fibrillation
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary elective CABG at the University of Utah Hospital
* Ability to provided informed consent and follow-up with protocol procedures

Exclusion Criteria:

* 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%

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 1 month
measure: Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls
timeFrame: 1 month
measure: proBNP (Serum) Between Groups at Time of Surgery
timeFrame: Surgery
measure: C-reactive Protein (Serum) Between Groups at Time of Surgery
timeFrame: Surgery
measure: Interleukin-6 (Serum) Between Groups at Time of Surgery
timeFrame: Surgery
measure: Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery
timeFrame: Surgery
measure: proBNP (Serum) Between Groups at 24 Hours Post-op
timeFrame: 24 hours
measure: C-reactive Protein (Serum) Between Groups at 24-hours Post-op
timeFrame: 24 hours
measure: Interleukin-6 (Serum) Between Groups at 24-hours Post-op
timeFrame: 24 hours
measure: Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op
timeFrame: 24 hours
measure: proBNP (Serum) Between Groups at 48 Hours Post-op
timeFrame: 48 hours
measure: C-reactive Protein (Serum) Between Groups at 48 Hours Post-op
timeFrame: 48 hours
measure: Interleukin-6 (Serum) Between Groups at 48 Hours Post-op
timeFrame: 48 hours
measure: Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op
timeFrame: 48 hours
measure: proBNP (Serum) Between Groups at 72 Hours Post-op
timeFrame: 72 hours
measure: CRP (Serum) Between Groups at 72 Hours Post-op
timeFrame: 72 hours
measure: Interleukin-6 (Serum) Between Groups at 72 Hours Post-op
timeFrame: 72 hours
measure: TNFa (Serum) Between Groups at 72 Hours Post-op
timeFrame: 72 hours
measure: proBNP (Serum) Between Groups at Follow-up
timeFrame: 1 month
measure: CRP (Serum) Between Groups at Follow-Up
timeFrame: 1 month
measure: Interleukin-6 (Serum) Between Groups at Follow-up
timeFrame: 1 month
measure: TNFa (Serum) Between Groups at Follow-up
timeFrame: 1 month
measure: proBNP (Pericardial Fluid) Between Groups at Time of Surgery
timeFrame: Surgery
measure: C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery
timeFrame: Surgery
measure: Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery
timeFrame: Surgery
measure: Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery
timeFrame: Surgery
measure: proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op
timeFrame: 24 hours
measure: C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op
timeFrame: 24 hours
measure: Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op
timeFrame: 24 hours
measure: Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op
timeFrame: 24 hours
measure: proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op
timeFrame: 48 hours
measure: C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op
timeFrame: 48 hours
measure: Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op
timeFrame: 48 hours
measure: Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op
timeFrame: 48 hours
measure: proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op
timeFrame: 72 hours
measure: C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op
timeFrame: 72 hours
measure: Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op
timeFrame: 72 hours
measure: Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Vikas Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: