Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-05 @ 12:32 PM
Study NCT ID:
NCT05403294
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2022-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2022-05-02', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'within 30 days of the procedure', 'description': 'Number of death at 30 days after surgery'}, {'measure': 'postoperative stroke', 'timeFrame': 'within 30 days of the procedure', 'description': 'Number of patients with postoperative stroke'}, {'measure': 'cardiac arrest', 'timeFrame': 'within 30 days of the procedure', 'description': 'number of patients with cardiac arrest'}, {'measure': 'new atrial fibrillation/flutter', 'timeFrame': 'within 30 days of the procedure', 'description': 'Number of Partients with new atrial fibrillation/flutter'}, {'measure': 'permanent rhythm device insertion', 'timeFrame': 'within 30 days of the procedure', 'description': 'Number of Patients requiring insertion of a permanent device'}], 'secondaryOutcomes': [{'measure': 'prolonged ventilation', 'timeFrame': 'within 30 days of the procedure', 'description': 'number of patients experiencing prolonged postoperative pulmonary ventilation (\\>24 hours)'}, {'measure': 'sepsis /deep sternal infection', 'timeFrame': 'within 30 days of the procedure', 'description': 'number of patients with sepsis, deep sternal wound infection or mediastinitis'}, {'measure': 'pulmonary complications', 'timeFrame': 'within 30 days of the procedure', 'description': 'number of patients with pneumonia or pleural effusion'}, {'measure': 'renal failure / renal dialysis', 'timeFrame': 'within 30 days of the procedure', 'description': 'number of patient with acute renal failure or worsening renal function result'}, {'measure': 'total intensive care unit (ICU) hours', 'timeFrame': 'within 30 days of the procedure', 'description': 'total intensive care unit (ICU) hours'}, {'measure': 'intensive care unit (ICU) readmissions', 'timeFrame': 'within 30 days of the procedure', 'description': 'number of patients with intensive care unit readmission'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Cardiometabolic Risk Factors', 'Cardiac Anesthesia', 'Cardiac Surgery', 'Anthropometry']}, 'descriptionModule': {'briefSummary': 'Obesity is associated with a number of risk factors for cardiovascular disease. Body mass index (BMI) is the most commonly recommended and used anthropometric measure to classify general obesity in clinical and epidemiological studies. It is widely accepted that obesity increases the risk of heart disease and is thought to be a risk factor for adverse outcomes after cardiac surgery. However, recent studies show paradoxical results, wherein obese patients can experience fewer adverse events and lower mortality than patients with normal-low body mass index(BMI) . The discriminative capacity of BMI has been criticized because it cannot distinguish muscle mass from fat mass, or reflect fat distribution . Alternatively, abdominal obesity indices, such as waist circumference (WC) and waist-to-height ratio (WHtR), have been suggested to be better predictor of cardiometabolic abnormalities because they modulate the limitation of BMI. However, they were insufficient in studies.For this reason, scientists turned to find a new anthropometric formula that could better detect obesity-related mortality and morbidity and they developed 2 new methods. Body Shape İndex (ABSI) is calculated using waist circumference, BMI and height parameters. Body Roundness İndex (BRI) is calculated using waist circumference and height parameters. These new indices may reflect visceral adiposity and strongly predict cardiovascular risk, postsurgical outcomes and resource utilisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over the age of 18 who have undergone open heart surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* open heart surgery\n* voluntary patients\n\nExclusion Criteria:\n\n* emergency surgery\n* off-pump or robotic surgery\n* surgery requiring deep hypothermic circulatory arrest\n* reluctant patients'}, 'identificationModule': {'nctId': 'NCT05403294', 'briefTitle': 'Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery', 'orgStudyIdInfo': {'id': '2022/02'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'MERVE SAHINGOZ', 'investigatorAffiliation': 'TC Erciyes University'}}}}