Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-31 @ 10:31 AM
Study NCT ID:
NCT00732459
Status:
UNKNOWN
Last Update Posted:
2008-08-18
First Post:
2008-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement 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': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-08-15', 'studyFirstSubmitDate': '2008-08-09', 'studyFirstSubmitQcDate': '2008-08-11', 'lastUpdatePostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'late loss', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['myocardial protection', 'cardiac surgery', 'heart valve replacement'], 'conditions': ['Rheumatic Valve Disease']}, 'referencesModule': {'references': [{'pmid': '20172127', 'type': 'DERIVED', 'citation': 'Yang L, Yang J, Wang Q, Chen M, Lu Z, Chen S, Xiong L. Cardioprotective effects of electroacupuncture pretreatment on patients undergoing heart valve replacement surgery: a randomized controlled trial. Ann Thorac Surg. 2010 Mar;89(3):781-6. doi: 10.1016/j.athoracsur.2009.12.003.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery.', 'detailedDescription': 'Heart valve replacement surgery has been proved to be an effective method in treating both regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass (CPB) and operation related myocardial injury, as indicated by the release of perioperative cardiac enzymes, is associated with worse patient morbidity and mortality after elective valve replacement surgery. Although the actual mechanism is still unclear, it has been shown that ischemic preconditioning is one potential strategy for reduction of myocardial injury in open heart surgery. Recently, Electro- acupuncture (EA) was proved to produced cerebral protective and antiarrhythmic effects by mimicking ischemic preconditioning. This study aims to assess whether electroacupuncture preconditioning is also effective in reducing myocardial injury in adults with acquired heart valve disease undergoing elective valve replacement surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study enrolls a group of 40-65years patients who have heart valve disease who need valve replacement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have the indication for aortic or mitral valve replacement\n* patients would like to accept the follow-up and sign the informed consent\n* patients with heart function of NYHA I-III degree.\n\nExclusion Criteria:\n\n* pregnant or nursing women\n* comorbid with coronary artery disease\n* patients with heart function of NYHA IV degree\n* renal dysfunction with serum creatinine level\\>or=2mg/dl(177umol/L)\n* anticipated life span \\< 12 months\n* enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.'}, 'identificationModule': {'nctId': 'NCT00732459', 'briefTitle': 'Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery', 'orgStudyIdInfo': {'id': 'XJ-20080808'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'electro-acupuncture preconditioning group', 'interventionNames': ['Device: Electro-acupuncture preconditioning']}, {'label': '2', 'description': 'control group'}], 'interventions': [{'name': 'Electro-acupuncture preconditioning', 'type': 'DEVICE', 'otherNames': ['Huatuo Brand', 'Type SDZ-II'], 'description': 'electro-acupuncture', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Department of Anesthesiology of Xijing Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Lize Xiong, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Director of Department of Anasthesiology of Xijing Hospital, Fourth Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Lize Xiong / Director of Department of Anasthesiology of Xijing Hospital', 'oldOrganization': 'Xijing Hospital of Fourth Military Military Medical University'}}}}