Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT06012994
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2023-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of the Protective Effect of Gastrodin on Myocardium in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-25', 'studyFirstSubmitDate': '2023-08-20', 'studyFirstSubmitQcDate': '2023-08-25', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of myocardial injury', 'timeFrame': 'The myocardial tissue was collected during the operation. About 2 hours on average', 'description': 'The myocardial tissue trimmed by the surgeon according to the surgical requirements was collected during the operation for electron microscopy observation and detection of related molecular content.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgical Procedures']}, 'descriptionModule': {'briefSummary': "Retrospective collection of Wuhan Union hospital from December 1,2018 to June 30,2021 to meet the entry and discharge standards. The patient 's medical record data were divided into study group and control group according to the use of gastrodin during operation. The perioperative data and prognostic outcomes in the patient 's medical records were collected and analyzed. The degree of myocardial injury and postoperative clinical outcomes were compared between the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study included patients who were preoperatively diagnosed as requiring elective thoracic cardiac surgery under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients agedā„18 years, regardless of gender;\n* Patients undergoing elective cardiac surgery under general anesthesia;\n* ASA grade 1 \\~ 3.\n\nExclusion Criteria:\n\n* Suffering from more serious genetic diseases (such as immunodeficiency, thalassemia, etc.);\n* Moderate to severe malnutrition, moderate to severe anemia;\n* Persistent infection;\n* Severe preoperative underlying diseases (such as severe liver and kidney dysfunction)'}, 'identificationModule': {'nctId': 'NCT06012994', 'briefTitle': 'Retrospective Study of the Protective Effect of Gastrodin on Myocardium in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Retrospective Study of the Protective Effect of Gastrodin on Myocardium in Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'mzk202303'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GAS'}, {'label': 'Control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}