Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-28 @ 11:02 AM
Study NCT ID:
NCT06012968
Status:
UNKNOWN
Last Update Posted:
2023-08-28
First Post:
2023-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, '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': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of myocardial cell injury', 'timeFrame': 'During postoperative hospitalization stay, an average of about two weeks', 'description': 'Postoperative myocardial injury marker serum concentration, postoperative cardiac function ultrasound index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgical Procedures']}, 'descriptionModule': {'briefSummary': "This study intends to include hypertrophic cardiomyopathy patients over 18 years old who underwent cardiac surgery in our hospital. Patients were divided into medication group and control group according to the use of gastrodin during operation. The patients ' myocardial tissue samples were collected, the postoperative prognosis data were observed and recorded, and the data were analyzed. The degree of myocardial tissue cell damage and postoperative clinical outcomes were compared between the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients included in this study were preoperatively diagnosed as hypertrophic cardiomyopathy.\n\nDiagnosis of hypertrophic cardiomyopathy: according to the medical history and physical examination, echocardiography showed diastolic ventricular septal thickness of 15 mm.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hypertrophic cardiomyopathy agedā„18 years, regardless of gender;\n* Patients undergoing elective hypertrophic cardiomyopathy outflow tract surgery;\n* Signed informed consent, good compliance.\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': 'NCT06012968', 'briefTitle': 'Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'mzk202301'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GAS'}, {'label': 'Control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingping Wu', 'role': 'CONTACT', 'email': 'wqp1968@163.com'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qingping Wu, doctor', 'role': 'CONTACT', 'email': 'wqp1968@126.com', 'phone': '13971605283'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}