Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

Early Phase 1

Completed

• Conditions: Atrial Fibrillation
• Interventions: Biological: Human Amniotic Membrane

• Registration Number: NCT04130061
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-11
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Results First Submitted: 2022-05-09
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Results First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized	Human Amniotic Membrane	-

Primary Outcome Measures

Name	Time	Method
Interleukin-6 (Serum) Between Groups at 48 Hours Post-op	48 hours	Comparison of IL-6 serum results between groups at 48 hours post-op
Number of Participants With Adverse Events	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	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	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	Surgery	Comparison of serum levels of CRP between groups at the time of surgery (baseline).
Interleukin-6 (Serum) Between Groups at Time of Surgery	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	Surgery	Comparison of serum levels of TNFa between groups at the time of surgery (baseline).
proBNP (Serum) Between Groups at 24 Hours Post-op	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	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	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	24 hours	Comparison of serum levels of TNFa between groups at 24 hours post-op
proBNP (Serum) Between Groups at 48 Hours Post-op	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	48 hours	Comparison of serum CRP levels between groups at 48 hours post-op
Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op	48 hours	Comparison of serum TNFa levels between groups at 48 hours post-op
proBNP (Serum) Between Groups at 72 Hours Post-op	72 hours	Comparison of serum levels of proBNP between groups at 72 hour post-op
CRP (Serum) Between Groups at 72 Hours Post-op	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	72 hours	Comparison of IL-6 serum levels between groups at 72 hours post-op
TNFa (Serum) Between Groups at 72 Hours Post-op	72 hours	Comparison of TNFa serum levels between groups at 72 hours post-op
proBNP (Serum) Between Groups at Follow-up	1 month	Comparison of serum levels of proBNP between groups at follow-up
CRP (Serum) Between Groups at Follow-Up	1 month	Comparison of serum CRP levels between groups at follow-up
Interleukin-6 (Serum) Between Groups at Follow-up	1 month	Comparison of IL-6 serum levels between groups at follow-up
TNFa (Serum) Between Groups at Follow-up	1 month	Comparison of TNFa serum levels between groups at follow-up
proBNP (Pericardial Fluid) Between Groups at Time of Surgery	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	72 hours	Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States