Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-13 @ 9:50 AM
Study NCT ID:
NCT01507805
Status:
UNKNOWN
Last Update Posted:
2012-01-11
First Post:
2011-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-08', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2012-01-08', 'lastUpdatePostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of myocardial ischemic injury markers,including serum level of c-reactive protein and Troponin I', 'timeFrame': '10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation', 'description': 'to observe the change of the level of multiple myocardial ischemic injury markers at the different time points.'}], 'secondaryOutcomes': [{'measure': 'The change of ST segment of EEG at different time points', 'timeFrame': '10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation'}, {'measure': 'Cardiac ultrasonic scan', 'timeFrame': 'five days pre-operation , five days post-operation', 'description': 'be aware of cardiac function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Electroacupuncture', 'preconditioning', 'Non-cardiac surgery', 'Coronary heart disease'], 'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe whether the electroacupuncture (EA) preconditioning for five days before operation can improve the outcomes of patients with coronary heart disease undergoing geriatric non-cardiac surgery.', 'detailedDescription': 'BACKGROUND:\n\nWith the development of surgical techniques, more and more people with coronary heart disease underwent non-cardiac surgery, which include abdominal, urologic, orthopedic surgeries. Due to the vulnerable heart function, geriatric patients suffer high incidence of cardiovascular events during the peri-operative period. Some studies found that EA preconditioning have a protective effect for the patients underwent Cardiac surgery. But non one addresses the effects of EA preconditioning on the outcomes of the patients with coronary heart disease who undergo non-cardiac surgery.\n\nDESIGNING:\n\nThe patients with coronary heart disease who will receive abdominal surgery will be randomly assigned into EA preconditioning group and control group. The patients in EA preconditioning group was treated at bilateral Neiguan (PC 6)，Lieque (LU 7) and Yunmen (LU 2) with electrical stimulation (5-30 Hz，2．34-6．24 mA，30 min) for 5 consecutive days before surgery．Before operation and before surgery, after surgery, 24h, 72h post surgery, all patients will be subjected to test the serum level of c-reactive protein and Troponin I. The EEG and heart ultrasonic exam will be used to evaluate the condition and function of heart before and after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective abdominal surgery with coronary heart disease\n\nExclusion Criteria:\n\n* serious bradycardiac arrythmia'}, 'identificationModule': {'nctId': 'NCT01507805', 'briefTitle': 'Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Effects of Electroacupuncture Preconditioning on Outcomes of the Geriatric Patients With Coronary Heart Disease Undergoing Non-cardiac Surgery', 'orgStudyIdInfo': {'id': 'csyxijing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EA preconditioning', 'description': 'electroacupuncture five days pre-operation', 'interventionNames': ['Device: EA preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham EA preconditioning', 'description': 'Patients treated with sham EA preconditioning Intervention', 'interventionNames': ['Device: sham EA preconditioning']}], 'interventions': [{'name': 'EA preconditioning', 'type': 'DEVICE', 'otherNames': ['Huantuo sdz-Ⅱ,Suzhou Medical Limit'], 'description': 'EA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)with electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery', 'armGroupLabels': ['EA preconditioning']}, {'name': 'sham EA preconditioning', 'type': 'DEVICE', 'description': 'Patients in Sham EA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)without electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery', 'armGroupLabels': ['Sham EA preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaoyang Xiao, Ph.D., M.D.', 'role': 'CONTACT', 'email': 'xiaozhaoy2006@hotmail.com', 'phone': '86 15009250798'}, {'name': 'Shaoyang Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xijing hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Shaoyang Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital, the Fourth Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}