Sponsor study identifier
Secondary identifiers
NIH
interventional
27
1 country
1
Study Start
October 11, 2019
Actual (reported)Primary Completion
June 1, 2021
Actual (reported)Study Completion
June 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2019
Actual (reported)October 14, 2019
Actual (reported)October 17, 2019
Actual (reported)June 1, 2021
Actual (reported)June 1, 2021
Actual (reported)December 6, 2024
Actual (reported)Number of Participants With Adverse Events
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).
1 month
Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls
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.
1 month
proBNP (Serum) Between Groups at Time of Surgery
Comparison of serum levels of proBNP between groups at the time of surgery (baseline).
Surgery
C-reactive Protein (Serum) Between Groups at Time of Surgery
Comparison of serum levels of CRP between groups at the time of surgery (baseline).
Surgery
Interleukin-6 (Serum) Between Groups at Time of Surgery
Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline).
Surgery
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery
Comparison of serum levels of TNFa between groups at the time of surgery (baseline).
Surgery
proBNP (Serum) Between Groups at 24 Hours Post-op
Comparison of serum proBNP levels between groups at 24 hours post-op
24 hours
C-reactive Protein (Serum) Between Groups at 24-hours Post-op
Comparison of serum measurements of CRP between groups at 24 hours post-op
24 hours
Interleukin-6 (Serum) Between Groups at 24-hours Post-op
Comparison of IL-6 serum levels between groups at 24 hours post-op
24 hours
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op
Comparison of serum levels of TNFa between groups at 24 hours post-op
24 hours
proBNP (Serum) Between Groups at 48 Hours Post-op
Comparison of serum levels of proBNP between groups at 48 hours post-op
48 hours
C-reactive Protein (Serum) Between Groups at 48 Hours Post-op
Comparison of serum CRP levels between groups at 48 hours post-op
48 hours
Interleukin-6 (Serum) Between Groups at 48 Hours Post-op
Comparison of IL-6 serum results between groups at 48 hours post-op
48 hours
Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op
Comparison of serum TNFa levels between groups at 48 hours post-op
48 hours
proBNP (Serum) Between Groups at 72 Hours Post-op
Comparison of serum levels of proBNP between groups at 72 hour post-op
72 hours
CRP (Serum) Between Groups at 72 Hours Post-op
Comparison of serum levels of CRP between groups at 72 hour post-op
72 hours
Interleukin-6 (Serum) Between Groups at 72 Hours Post-op
Comparison of IL-6 serum levels between groups at 72 hours post-op
72 hours
TNFa (Serum) Between Groups at 72 Hours Post-op
Comparison of TNFa serum levels between groups at 72 hours post-op
72 hours
proBNP (Serum) Between Groups at Follow-up
Comparison of serum levels of proBNP between groups at follow-up
1 month
CRP (Serum) Between Groups at Follow-Up
Comparison of serum CRP levels between groups at follow-up
1 month
Interleukin-6 (Serum) Between Groups at Follow-up
Comparison of IL-6 serum levels between groups at follow-up
1 month
TNFa (Serum) Between Groups at Follow-up
Comparison of TNFa serum levels between groups at follow-up
1 month
proBNP (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline)
Surgery
C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline).
Surgery
Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline).
Surgery
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline).
Surgery
proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op
24 hours
C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op
24 hours
Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op
24 hours
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of TNFa in pericardial fluid between groups at 24 hours post-op.
24 hours
proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op.
48 hours
C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op
48 hours
Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op
48 hours
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op
48 hours
proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op
72 hours
C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op
72 hours
Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op
72 hours
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op
72 hours
Epicardial application of human amniotic membrane during cardiac surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Utah
Salt Lake City, Utah, 84132, United States
Vikas Sharma, MD
University of Utah
27 participants (actual enrollment reported by the registry).
First Submitted
October 14, 2019
First Posted
October 17, 2019
Study Start
October 11, 2019
Actual (reported)Arterial Stiffness and Atrial Fibrillation
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2021
Actual (reported)Study Completion
June 1, 2021
Actual (reported)Last Updated
April 9, 2026
Results First Posted
December 6, 2024
Record last verified: 2024-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: