Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT04639856
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2020-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001026', 'term': 'Coronary Artery Bypass'}], 'ancestors': [{'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-20', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU Stay', 'timeFrame': '6 Months', 'description': 'post operative ICU stay in patients undergoing cardiac revascularization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Bypass Grafting'], 'conditions': ['Cardiac Revascularization']}, 'descriptionModule': {'briefSummary': 'Coronary artery bypass graft (CABG) surgery can result in severe postoperative complications, such as renal and pulmonary failure. In about 80% of the cases worldwide, it is currently performed with cardiopulmonary bypass (CPB) with cardiac arrest. Cardiopulmonary bypass leads to a systemic inflammatory response, which may be induced by the contact of circulating blood with artificial surfaces of the extracorporeal circuit.\\[1\\] To reduce postoperative complications caused by systemic inflammation, off-pump CABG was reintroduced into clinical practice in the early 1990s. During off-pump surgery, the coronary artery grafts are placed on coronaries of a beating heart, thereby avoiding aortic cross clamping and CPB. \\[1\\] There are many studies and debates about the two approaches to cardiac revascularization via CABG. This study aims to answer the question as to difference in the ICU stay of patients with low ejection fraction undergoing cardiac revascularization bet ween off pump and on pump coronary artery bypass grafting and better treatment option shall be adopted in future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients of either gender between the ages of 40 to 80\n* Ejection fraction of less than or equal to 35% undergoing CABG.\n* undergoing CABG.\n\nExclusion Criteria:\n\n* Patients with ejection fraction of more than 35%\n* Patients with previous history of cardiac revascularization\n* Patients with previous history of chronic kidney disease and obstructive sleep apnea.'}, 'identificationModule': {'nctId': 'NCT04639856', 'briefTitle': 'ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting', 'organization': {'class': 'OTHER', 'fullName': 'Armed Forces Institute of Cardiology, Pakistan'}, 'officialTitle': 'ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'AFIC-IERB-SOP-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'on-pump CABG', 'description': 'CABG using Cardiopulmonary Bypass Machine', 'interventionNames': ['Procedure: Coronary Artery Bypass Grafting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'off-pump CABG', 'description': 'CABG without Cardiopulmonary Bypass Machine', 'interventionNames': ['Procedure: Coronary Artery Bypass Grafting']}], 'interventions': [{'name': 'Coronary Artery Bypass Grafting', 'type': 'PROCEDURE', 'description': 'on-pump vs off pump Coronary artery Bypass Grafting', 'armGroupLabels': ['off-pump CABG', 'on-pump CABG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Rawalpindi', 'country': 'Pakistan', 'facility': 'Armed Forces Institute of Cardiology, Rawalpindi', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armed Forces Institute of Cardiology, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiac Surgeon', 'investigatorFullName': 'Muhammad Bilal', 'investigatorAffiliation': 'Armed Forces Institute of Cardiology, Pakistan'}}}}