Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT04130061
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2019-10-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vikas.sharma@hsc.utah.edu', 'phone': '801-581-5311', 'title': 'Vikas Sharma, MD', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days post-hospital discharge', 'eventGroups': [{'id': 'EG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG who randomized to receive amniotic membrane', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG who randomized to receive standard of care', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', '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).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG who randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG who randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': "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.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'proBNP (Serum) Between Groups at Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG who randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG who randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'spread': '263', 'groupId': 'OG000'}, {'value': '347', 'spread': '523', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Surgery', 'description': 'Comparison of serum levels of proBNP between groups at the time of surgery (baseline).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (Serum) Between Groups at Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG who randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG who randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Surgery', 'description': 'Comparison of serum levels of CRP between groups at the time of surgery (baseline).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 (Serum) Between Groups at Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.25', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Surgery', 'description': 'Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.45', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '3.63', 'spread': '3.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Surgery', 'description': 'Comparison of serum levels of TNFa between groups at the time of surgery (baseline).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'proBNP (Serum) Between Groups at 24 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '1922.83', 'spread': '1017.9', 'groupId': 'OG000'}, {'value': '2239.42', 'spread': '2384.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Comparison of serum proBNP levels between groups at 24 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (Serum) Between Groups at 24-hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '14.94', 'spread': '5.94', 'groupId': 'OG000'}, {'value': '10.66', 'spread': '4.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Comparison of serum measurements of CRP between groups at 24 hours post-op', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 (Serum) Between Groups at 24-hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '26.95', 'spread': '22.36', 'groupId': 'OG000'}, {'value': '18.28', 'spread': '12.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Comparison of IL-6 serum levels between groups at 24 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.61', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '2.87', 'spread': '2.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Comparison of serum levels of TNFa between groups at 24 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'proBNP (Serum) Between Groups at 48 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '6081.83', 'spread': '5134.12', 'groupId': 'OG000'}, {'value': '7750.35', 'spread': '7474.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Comparison of serum levels of proBNP between groups at 48 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (Serum) Between Groups at 48 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '21.67', 'spread': '8.18', 'groupId': 'OG000'}, {'value': '15.71', 'spread': '6.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Comparison of serum CRP levels between groups at 48 hours post-op', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 (Serum) Between Groups at 48 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '12.32', 'spread': '10.01', 'groupId': 'OG000'}, {'value': '14.39', 'spread': '10.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Comparison of IL-6 serum results between groups at 48 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.34', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Comparison of serum TNFa levels between groups at 48 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'proBNP (Serum) Between Groups at 72 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2707.75', 'spread': '925.9', 'groupId': 'OG000'}, {'value': '449.71', 'spread': '6191.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Comparison of serum levels of proBNP between groups at 72 hour post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'CRP (Serum) Between Groups at 72 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '17.45', 'spread': '5.95', 'groupId': 'OG000'}, {'value': '14.21', 'spread': '5.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Comparison of serum levels of CRP between groups at 72 hour post-op', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 (Serum) Between Groups at 72 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '5.81', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '10.38', 'spread': '8.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Comparison of IL-6 serum levels between groups at 72 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'TNFa (Serum) Between Groups at 72 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.12', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '1.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Comparison of TNFa serum levels between groups at 72 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'proBNP (Serum) Between Groups at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '847', 'spread': '505.79', 'groupId': 'OG000'}, {'value': '1391.7', 'spread': '1336.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Comparison of serum levels of proBNP between groups at follow-up', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'CRP (Serum) Between Groups at Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.975', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '3.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Comparison of serum CRP levels between groups at follow-up', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 (Serum) Between Groups at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.37', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '15.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Comparison of IL-6 serum levels between groups at follow-up', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'TNFa (Serum) Between Groups at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.11', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '3.11', 'spread': '2.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Comparison of TNFa serum levels between groups at follow-up', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'proBNP (Pericardial Fluid) Between Groups at Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '1039.6', 'spread': '819.58', 'groupId': 'OG000'}, {'value': '1771.07', 'spread': '2332.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Surgery', 'description': 'Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Surgery', 'description': 'Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '26.17', 'groupId': 'OG000'}, {'value': '59.9', 'spread': '122.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Surgery', 'description': 'Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '2.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Surgery', 'description': 'Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '6081.83', 'spread': '5134.12', 'groupId': 'OG000'}, {'value': '7750.35', 'spread': '7474.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '4.54', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '88823.8', 'spread': '51901.4', 'groupId': 'OG000'}, {'value': '67217.8', 'spread': '48407.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Comparison of IL-6 levels in 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'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '64370.14', 'spread': '57497', 'groupId': 'OG000'}, {'value': '45839.95', 'spread': '43229.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '7.81', 'groupId': 'OG000'}, {'value': '8.03', 'spread': '5.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '3895.5', 'spread': '1458.8', 'groupId': 'OG000'}, {'value': '8423', 'spread': '5911.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '8.53', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '9296.6', 'spread': '9514', 'groupId': 'OG000'}, {'value': '25316.6', 'spread': '39863.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '12.32', 'spread': '13.44', 'groupId': 'OG000'}, {'value': '8.38', 'spread': '4.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG who randomized to receive amniotic membrane'}, {'id': 'FG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG who randomized to receive standard of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'OR team forgot to request membrane', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment in a University hospital (inpatient, outpatient clinics) from October 2019 through May 2021', 'preAssignmentDetails': 'One participant was enrolled and randomized to receive the intervention, but they ultimately did not have the membrane placed due to a miscommunication in the OR. This is the reason that 27 participants were enrolled but the total number for analysis was 26.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane'}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients undergoing isolated CABG surgery who are randomized to receive standard of care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.91', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '76'}, {'value': '65.78', 'groupId': 'BG001', 'lowerLimit': '49', 'upperLimit': '81'}, {'value': '65.38', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-01', 'size': 165139, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-09T14:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2019-10-14', 'resultsFirstSubmitDate': '2022-05-09', 'studyFirstSubmitQcDate': '2019-10-15', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-03', 'studyFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '1 month', '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)."}, {'measure': 'Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls', 'timeFrame': '1 month', 'description': "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."}, {'measure': 'proBNP (Serum) Between Groups at Time of Surgery', 'timeFrame': 'Surgery', 'description': 'Comparison of serum levels of proBNP between groups at the time of surgery (baseline).'}, {'measure': 'C-reactive Protein (Serum) Between Groups at Time of Surgery', 'timeFrame': 'Surgery', 'description': 'Comparison of serum levels of CRP between groups at the time of surgery (baseline).'}, {'measure': 'Interleukin-6 (Serum) Between Groups at Time of Surgery', 'timeFrame': 'Surgery', 'description': 'Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline).'}, {'measure': 'Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery', 'timeFrame': 'Surgery', 'description': 'Comparison of serum levels of TNFa between groups at the time of surgery (baseline).'}, {'measure': 'proBNP (Serum) Between Groups at 24 Hours Post-op', 'timeFrame': '24 hours', 'description': 'Comparison of serum proBNP levels between groups at 24 hours post-op'}, {'measure': 'C-reactive Protein (Serum) Between Groups at 24-hours Post-op', 'timeFrame': '24 hours', 'description': 'Comparison of serum measurements of CRP between groups at 24 hours post-op'}, {'measure': 'Interleukin-6 (Serum) Between Groups at 24-hours Post-op', 'timeFrame': '24 hours', 'description': 'Comparison of IL-6 serum levels between groups at 24 hours post-op'}, {'measure': 'Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op', 'timeFrame': '24 hours', 'description': 'Comparison of serum levels of TNFa between groups at 24 hours post-op'}, {'measure': 'proBNP (Serum) Between Groups at 48 Hours Post-op', 'timeFrame': '48 hours', 'description': 'Comparison of serum levels of proBNP between groups at 48 hours post-op'}, {'measure': 'C-reactive Protein (Serum) Between Groups at 48 Hours Post-op', 'timeFrame': '48 hours', 'description': 'Comparison of serum CRP levels between groups at 48 hours post-op'}, {'measure': 'Interleukin-6 (Serum) Between Groups at 48 Hours Post-op', 'timeFrame': '48 hours', 'description': 'Comparison of IL-6 serum results between groups at 48 hours post-op'}, {'measure': 'Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op', 'timeFrame': '48 hours', 'description': 'Comparison of serum TNFa levels between groups at 48 hours post-op'}, {'measure': 'proBNP (Serum) Between Groups at 72 Hours Post-op', 'timeFrame': '72 hours', 'description': 'Comparison of serum levels of proBNP between groups at 72 hour post-op'}, {'measure': 'CRP (Serum) Between Groups at 72 Hours Post-op', 'timeFrame': '72 hours', 'description': 'Comparison of serum levels of CRP between groups at 72 hour post-op'}, {'measure': 'Interleukin-6 (Serum) Between Groups at 72 Hours Post-op', 'timeFrame': '72 hours', 'description': 'Comparison of IL-6 serum levels between groups at 72 hours post-op'}, {'measure': 'TNFa (Serum) Between Groups at 72 Hours Post-op', 'timeFrame': '72 hours', 'description': 'Comparison of TNFa serum levels between groups at 72 hours post-op'}, {'measure': 'proBNP (Serum) Between Groups at Follow-up', 'timeFrame': '1 month', 'description': 'Comparison of serum levels of proBNP between groups at follow-up'}, {'measure': 'CRP (Serum) Between Groups at Follow-Up', 'timeFrame': '1 month', 'description': 'Comparison of serum CRP levels between groups at follow-up'}, {'measure': 'Interleukin-6 (Serum) Between Groups at Follow-up', 'timeFrame': '1 month', 'description': 'Comparison of IL-6 serum levels between groups at follow-up'}, {'measure': 'TNFa (Serum) Between Groups at Follow-up', 'timeFrame': '1 month', 'description': 'Comparison of TNFa serum levels between groups at follow-up'}, {'measure': 'proBNP (Pericardial Fluid) Between Groups at Time of Surgery', 'timeFrame': 'Surgery', 'description': 'Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline)'}, {'measure': 'C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery', 'timeFrame': 'Surgery', 'description': 'Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline).'}, {'measure': 'Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery', 'timeFrame': 'Surgery', 'description': 'Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline).'}, {'measure': 'Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery', 'timeFrame': 'Surgery', 'description': 'Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline).'}, {'measure': 'proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op', 'timeFrame': '24 hours', 'description': 'Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op'}, {'measure': 'C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op', 'timeFrame': '24 hours', 'description': 'Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op'}, {'measure': 'Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op', 'timeFrame': '24 hours', 'description': 'Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op'}, {'measure': 'Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op', 'timeFrame': '24 hours', 'description': 'Comparison of TNFa in pericardial fluid between groups at 24 hours post-op.'}, {'measure': 'proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op', 'timeFrame': '48 hours', 'description': 'Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op.'}, {'measure': 'C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op', 'timeFrame': '48 hours', 'description': 'Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op'}, {'measure': 'Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op', 'timeFrame': '48 hours', 'description': 'Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op'}, {'measure': 'Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op', 'timeFrame': '48 hours', 'description': 'Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op'}, {'measure': 'proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op', 'timeFrame': '72 hours', 'description': 'Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op'}, {'measure': 'C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op', 'timeFrame': '72 hours', 'description': 'Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op'}, {'measure': 'Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op', 'timeFrame': '72 hours', 'description': 'Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op'}, {'measure': 'Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op', 'timeFrame': '72 hours', 'description': 'Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing primary elective CABG at the University of Utah Hospital\n* Ability to provided informed consent and follow-up with protocol procedures\n\nExclusion Criteria:\n\n* Patients in AF at the time of surgery\n* Prior history of sternotomy\n* Prior history of pericarditis\n* Currently on aggressive antiarrhythmic therapy (does not include beta blockers)\n* Patients with an implantable cardiac device (pacemaker, ICD, CRT-D)\n* Ejection fraction \\<45%'}, 'identificationModule': {'nctId': 'NCT04130061', 'briefTitle': 'Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Safety and Feasibility Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation After Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': '00113483'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomized', 'interventionNames': ['Biological: Human Amniotic Membrane']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Human Amniotic Membrane', 'type': 'BIOLOGICAL', 'description': 'Epicardial application of human amniotic membrane during cardiac surgery', 'armGroupLabels': ['Randomized']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Vikas Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Vikas Sharma', 'investigatorAffiliation': 'University of Utah'}}}}