Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-05 @ 5:38 PM
Study NCT ID:
NCT02534103
Status:
COMPLETED
Last Update Posted:
2020-08-07
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between a Combined Index of Diastolic and Systolic Performance and Intraoperative Hemodynamic Changes During Off-pump Coronary Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-05', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-08-24', 'lastUpdatePostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sequential changes of SvO2', 'timeFrame': 'during OPCAB surgery', 'description': 'Mixed venous oxygen saturation(SvO2) reflects the balance of oxygen supply and demand immediately. Cardiac index(CI) also is a useful marker of how well the heart is functioning. Both variables can show the hemodynamic instability. With the comparison of EAS index and variables including SvO2 and CI, Investigator may draw the predictable value of the EAS index for predicting hemodynamic instability during OPCAB.'}, {'measure': 'sequential changes of CI', 'timeFrame': 'during OPCAB surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Obstructive Disease']}, 'descriptionModule': {'briefSummary': "As considering the close relationship between systolic dysfunction and diastolic dysfunction, the EAS index e'/(a' x s') including systolic and diastolic function could be expected to predict hemodynamic changes during off-pump coronary artery bypass surgery(OPCAB). Exposure of the grafting site during OPCAB needs displacement of the heart, resulting in hemodynamic instability.\n\nTherefore the investigators are going to evaluate EAS index with preoperative Transthoracic echocardiography(TTE) and want to know the relationship between preoperative EAS index and intraoperative hemodynamic changes in patients undergoing OPCAB, in a prospective observational study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with coronary artery obstructive disease planned to have multivessel OPCAB', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 20\n2. Patients undergoing multivessel off-pump coronary artery bypass surgery\n\nExclusion Criteria:\n\n1. Age \\< 20\n2. Patients with valvular heart disease\n3. Congestive heart failure, NYHA class ≥III\n4. Emergency surgery\n5. Patients with arrhythmia\n6. ST segment elevation myocardial infarction'}, 'identificationModule': {'nctId': 'NCT02534103', 'briefTitle': 'Relationship Between a Combined Index of Diastolic and Systolic Performance and Intraoperative Hemodynamic Changes During Off-pump Coronary Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0879'}}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Kwang Shim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}