Back to resultsHuman Amniotic Membrane to Decrease Post Operative Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Human Amniotic Membrane
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
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%
Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Randomized
Control
Arm Description
Outcomes
Primary Outcome Measures
Safety assessment of the use of human amniotic membrane during cardiac surgery by incidence of 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).
Comparison of the incidence of Post Op Atrial Fibrillation between patients who receive hAM and controls
The incidence of 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.
Comparison of inflammatory response (systemic and pericardial) between patients who received hAM and controls
The proinflammatory response to cardiopulmonary bypass circuit as measured by numerous systemic and pericardial inflammatory markers i.e. C-reactive protein (CRP), TNF-α, Interleukin (IL)-6 and brain natriuretic peptide (BNP), have been linked to induction of atrial fibrillation. We will collect pericardial (from chest tubes) and systemic fluid markers at pre-specified intervals. We will assess the percentage change in the levels of the biomarkers as compared to their pre-operative baseline, as there will be expected variability in the level of these biomarkers at baseline.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04130061
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Randomized
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
Human Amniotic Membrane
Intervention Description
Epicardial application of human amniotic membrane during cardiac surgery
Primary Outcome Measure Information:
Title
Safety assessment of the use of human amniotic membrane during cardiac surgery by incidence of adverse events
Description
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).
Time Frame
1 month
Title
Comparison of the incidence of Post Op Atrial Fibrillation between patients who receive hAM and controls
Description
The incidence of 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.
Time Frame
1 month
Title
Comparison of inflammatory response (systemic and pericardial) between patients who received hAM and controls
Description
The proinflammatory response to cardiopulmonary bypass circuit as measured by numerous systemic and pericardial inflammatory markers i.e. C-reactive protein (CRP), TNF-α, Interleukin (IL)-6 and brain natriuretic peptide (BNP), have been linked to induction of atrial fibrillation. We will collect pericardial (from chest tubes) and systemic fluid markers at pre-specified intervals. We will assess the percentage change in the levels of the biomarkers as compared to their pre-operative baseline, as there will be expected variability in the level of these biomarkers at baseline.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vikas Sharma, MD
Phone
(801) 581-5311
Email
vikas.sharma@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Messina, MA
Phone
(801) 585-3752
Email
alyssa.messina@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikas Sharma, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikas Sharma, MD
Phone
801-581-5311
Email
vikas.sharma@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Alyssa Messina, MA
Phone
18015853752
Email
alyssa.messina@hsc.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation
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