Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT03275220
Status:
UNKNOWN
Last Update Posted:
2017-09-07
First Post:
2017-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D019560', 'term': 'Echocardiography, Three-Dimensional'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D021621', 'term': 'Imaging, Three-Dimensional'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-05', 'studyFirstSubmitDate': '2017-08-27', 'studyFirstSubmitQcDate': '2017-09-05', 'lastUpdatePostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of effects of CABG on right ventricular function', 'timeFrame': '6 months', 'description': 'assessment of right ventricular function in patients undergoing CABG using 2D echocardiography and 3D echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CORONARY ARTERY BYPASS']}, 'referencesModule': {'references': [{'pmid': '18941594', 'type': 'BACKGROUND', 'citation': 'Roshanali F, Yousefnia MA, Mandegar MH, Rayatzadeh H, Alinejad S. Decreased right ventricular function after coronary artery bypass grafting. Tex Heart Inst J. 2008;35(3):250-5.'}]}, 'descriptionModule': {'briefSummary': 'Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University', 'detailedDescription': 'Right ventricular (RV) dysfunction is a major risk factor in coronary artery disease (CAD) and patient undergoing revascularization with this combination , incidence of RV dysfunction is reported in about 20% cases of CAD.\n\nRV dysfunction is a possible cause of cardiac failure after cardiac surgery and has a high mortality rate.\n\nRV dysfunction is a recognized cause of hypotension early after coronary artery bypass graft surgery (CABG)\n\nA decrease in RV function is an event known to occur after CABG. Right ventricular dysfunction can be seen during and immediately after cardiac surgery. Although the mechanism of this phenomenon is not well understood, cardiopulmonary bypass, perioperative myocardial ischemia, intraoperative myocardial damage, cardioplegia, and pericardial disruption or adhesion have been suggested as probable causes.\n\nMajor reasons for complications of cardiac surgery are the need for hypothermic cardiac arrest, aortic cross clamping, and exposure to a cardiopulmonary bypass circuit.\n\nIt has been postulated that avoidance of these factors by performing off-pump coronary artery bypass (OPCAB) surgery might reduce perioperative morbidity and improve outcome.\n\nRecently, the portion of coronary artery bypass grafting on the beating heart without the use of cardiopulmonary bypass (CPB) has been expanded in cardiac surgery as a result of awareness of the damaging effect of CPB\n\nWhether OPCAB surgery can fulfill these expectations, or to which degree, is yet unclear.\n\nA few studies on hemodynamic alternations associated with OPCAB reported that reduced functions of both ventricles during coronary artery anastomosis are the main mechanism of hemodynamic derangements and especially, impaired diastolic function of the right ventricle (RV) plays an important role\n\nHowever, clinical studies evaluating the change in RV function in patients with ischemic heart disease are very rare. It is reported that the major cause of hemodynamic changes during OPCAB was disturbed diastolic filling of the RV through the measurement of chamber pressures or monitoring of echocardiography.\n\nThere was no significant change in the RVEF and cardiac index during anastomosis of the left anterior descending artery and right coronary artery. However, the significantly reduced RVEF accompanied by an increase in RV afterload and decrease in the CO was observed during anastomosis of the obtuse marginal (OM) artery. RV volumes did not significantly change during anastomoses, though the right atrial pressure increased during anastomoses of all coronary arteries. The displacement of beating heart for positioning during anastomosis of the graft to OM artery caused significant derangement of RV function and decrease in CO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include patients will undergo elective CABG of different ages from cardiology department, Assiut University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Inclusion criteria:\n\n • Patients will undergo elective CABG in Assiut university hospital\n2. Exclusion criteria:\n\n * Poor echo window.\n * Refusal of the patient\n * Patients with prior RV dysfunction.\n * Patients with LV dysfunction (EF:\\<40%).'}, 'identificationModule': {'nctId': 'NCT03275220', 'briefTitle': 'Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University', 'orgStudyIdInfo': {'id': '17100309'}}, 'armsInterventionsModule': {'interventions': [{'name': '2D Echocardiography and 3D Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Imaging of right ventricle by 2d echocardiography and 3D echocardiography to assess right ventricular function accurately'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17642', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Maria Refaat, master', 'role': 'CONTACT', 'email': 'Merofouad307@yahoo.com', 'phone': '01120108960'}, {'name': 'Salah Atta', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Salma Taha', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maria Refaat', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Maria Refaat, master', 'role': 'CONTACT', 'email': 'Merofouad307@yahoo.com', 'phone': '01120108960'}], 'overallOfficials': [{'name': 'Salah Atta', 'role': 'STUDY_CHAIR', 'affiliation': 'professor'}, {'name': 'Salma Taha', 'role': 'STUDY_CHAIR', 'affiliation': 'lecturer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mero Fouad', 'investigatorAffiliation': 'Assiut University'}}}}