Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-08 @ 9:45 PM
Study NCT ID:
NCT06468657
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002303', 'term': 'Cardiac Output, Low'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009026', 'term': 'Mortality'}, {'id': 'D014662', 'term': 'Vasoconstrictor Agents'}], 'ancestors': [{'id': 'D014798', 'term': 'Vital Statistics'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 610}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-06-15', 'studyFirstSubmitQcDate': '2024-06-15', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '30 days', 'description': 'mortality in 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Output, Low']}, 'descriptionModule': {'briefSummary': "This study evaluates the impact of ejection fraction (EF) on clinical outcomes in patients undergoing cardiovascular surgeries, specifically coronary artery bypass grafting (CABG) and heart valve replacement. It spans surgeries performed between 2012 and 2022 at Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. Patients are categorized into two groups based on their preoperative EF: those with preserved EF (≥50%) and those with reduced EF (\\<50%).\n\nThe primary aim is to assess how EF affects postoperative morbidity, mortality, hospital stay, and complications. Secondary aims include evaluating the development of postoperative arrhythmias, the need for vasopressors and inotropes, and transfusion requirements.\n\nData will be collected retrospectively from hospital records and electronic health systems. The study's findings are expected to provide insights into tailored perioperative and postoperative management strategies for patients with varying EF levels, ultimately improving clinical outcomes.", 'detailedDescription': "Primary Objective The primary objective of this study is to evaluate the impact of ejection fraction (EF) on clinical outcomes in patients undergoing cardiovascular surgery. Specifically, the study aims to analyze the effects of EF on postoperative morbidity and mortality rates, length of hospital stay, and postoperative complications.\n\nSecondary Objectives Secondary objectives include assessing the development of arrhythmias in the postoperative period, the need for vasopressors and inotropes, and the requirement for transfusions.\n\nScope of the Study Time Frame The study will encompass cardiovascular surgeries performed between 2012 and 2022. This time frame is selected to obtain a sufficient data set and evaluate long-term outcomes.\n\nResearch Center The study will be conducted at Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. Patient data from cardiovascular surgeries performed at this center will be analyzed.\n\nPatient Population The study will include all patients who underwent cardiovascular surgery within the specified time frame and had preoperative ejection fraction (EF) measurements.\n\nStudy Design Group Formation\n\nPatients will be divided into two main groups based on their preoperative EF values:\n\nPreserved EF Group: Patients with an EF of 50 or above. Reduced EF Group: Patients with an EF below 50. Data to be Examined\n\nThe following postoperative data will be examined and compared between the two groups:\n\nDevelopment of Postoperative Arrhythmias: Whether patients develop arrhythmias in the postoperative period.\n\nVasopressor Requirement: The need for vasopressors in the postoperative period. Inotrope Requirement: Whether patients require inotropic support postoperatively.\n\nTransfusion Requirement: The need for blood transfusions in the postoperative period.\n\nMortality: Survival rates of patients following surgery. Need for Revision Surgery: Whether patients require additional surgical interventions postoperatively.\n\nLength of Stay in ICU: Duration of patients' stay in the intensive care unit. Total Hospital Stay: Overall length of hospital stay. Data Collection Method Data will be retrospectively collected from hospital records and electronic health record (EHR) systems.\n\nThis structured approach aims to comprehensively evaluate the clinical outcomes of patients with varying levels of ejection fraction undergoing major cardiovascular surgeries, thereby providing insights that can enhance patient management strategies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A minimum of 210 patients who underwent cardiovascular surgery at Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital and had their ejection fraction (EF) measured in the preoperative period will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: Patients aged 18 years and older.\n* Cardiovascular Surgery: Patients who have undergone cardiovascular surgeries such as coronary artery bypass grafting (CABG), valve surgery, aortic surgery, etc.\n* Ejection Fraction (EF): Patients with documented EF measurements.\n\nExclusion Criteria:\n\n* Age: Patients under 18 years of age.\n* Non-Surgical Interventions: Patients undergoing procedures other than cardiovascular surgery.\n* Incomplete Data: Patients without documented EF measurements or with missing clinical data.\n* Pregnancy: Patients who are pregnant.'}, 'identificationModule': {'nctId': 'NCT06468657', 'briefTitle': 'Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery', 'orgStudyIdInfo': {'id': 'ejection fraction'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'reduced ejection fraction', 'description': 'EF below 50', 'interventionNames': ['Other: mortality rates']}, {'label': 'preserved ejection fraction', 'description': 'EF above 50', 'interventionNames': ['Other: mortality rates']}], 'interventions': [{'name': 'mortality rates', 'type': 'OTHER', 'otherNames': ['vasopressor/inotropic agent needs', 'transfusion needs', 'perioperative arrhythmias', 'intensive care stay'], 'description': 'mortality rates', 'armGroupLabels': ['preserved ejection fraction', 'reduced ejection fraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Engin ihsan Turan, Specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesiology and reanimation specialist', 'investigatorFullName': 'Engin Ihsan Turan', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}