- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130061
Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation
February 2, 2020 updated by: Vikas Sharma, University of Utah
Safety and Feasibility Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation After Coronary Artery Bypass Grafting
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- Recruiting
- University of Utah
-
Contact:
- Vikas Sharma, MD
- Phone Number: 801-581-5311
- Email: vikas.sharma@hsc.utah.edu
-
Contact:
- Alyssa Messina, MA
- Phone Number: 18015853752
- Email: alyssa.messina@hsc.utah.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Randomized
|
Epicardial application of human amniotic membrane during cardiac surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety assessment of the use of human amniotic membrane during cardiac surgery by incidence of adverse events
Time Frame: 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).
|
1 month
|
Comparison of the incidence of Post Op Atrial Fibrillation between patients who receive hAM and controls
Time Frame: 1 month
|
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.
|
1 month
|
Comparison of inflammatory response (systemic and pericardial) between patients who received hAM and controls
Time Frame: 1 month
|
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.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vikas Sharma, MD, University of Utah
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 11, 2019
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
October 14, 2019
First Submitted That Met QC Criteria
October 15, 2019
First Posted (Actual)
October 17, 2019
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 2, 2020
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00113483
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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