Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-07 @ 1:14 PM
Study NCT ID:
NCT03418194
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2018-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative HRV and Hs-cTnT of Elderly With CHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2018-01-25', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High-sensitive cardiac troponin T', 'timeFrame': '1 week', 'description': 'Cardiac troponin T are components of the contractile apparatus of myocardial cells and are expressed almost exclusively in the heart. High-sensitive cardiac troponin T is cardiac troponin T mesured by high-sensitive method.'}], 'secondaryOutcomes': [{'measure': 'heart rate variability', 'timeFrame': '1 week', 'description': 'Heart rate variability (HRV) has been verified as a noninvasive indicator of the autonomic nervous system.'}, {'measure': 'CK', 'timeFrame': '1 week', 'description': 'CK is an indicator that reflects the amplitude of operation injury in spine surgery. 1, 3 and 5d after surgery, the serum concentration of CK.'}, {'measure': 'CRP', 'timeFrame': '1 week', 'description': 'CRP is a non-specific biomarker of inflammation which has been described as a risk factor for cardiovascular disease. 1, 3 and 5d after surgery, the serum concentration of CRP.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia, General'], 'conditions': ['Coronary Artery Disease', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '21658013', 'type': 'RESULT', 'citation': 'Mazzeo AT, La Monaca E, Di Leo R, Vita G, Santamaria LB. Heart rate variability: a diagnostic and prognostic tool in anesthesia and intensive care. Acta Anaesthesiol Scand. 2011 Aug;55(7):797-811. doi: 10.1111/j.1399-6576.2011.02466.x. Epub 2011 Jun 9.'}, {'pmid': '28444280', 'type': 'RESULT', 'citation': 'Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to observe the effect of transcutaneous acupoint electrical stimulation (TAES) on postoperative heart rate variability and high-sensitive cardiac troponin T of elderly patients with coronary heart disease.', 'detailedDescription': 'General anesthesia can inhibit sympathetic nerve activity and attenuate stress response, but it also inhibits vagus nerve activity. The decrease of vagus nerve activity can cause cardiovascular complications, especially ventricular arrhythmia in patients with coronary heart disease. Some study have shown that electrical stimulation of transcutaneous acupoints can regulate the function of autonomic nervous system and enhance the activity of vagus nerve so as to protect myocardial tissue. But the effect on autonomic nervous function and myocardial injury markers in elderly patients with coronary heart disease was not reported. Heart rate variability (HRV) is a noninvasive and reliable index reflecting cardiac autonomic nervous function. High-sensitive cardiac troponin hs-cTnT is the best myocardial injury marker.\n\nThe investigators plan to recruite 150 patients with coronary heart disease of both sexes, aged 65-80 yr, undergoing elective lumbar decompression and fusion internal fixation surgery. They will be randomly divided into 2 groups(n=75 each)using random number table : control group ( group C ) and TAES group (group T). Patients in group T receive TEAS (disperse-dense waves, frequency 4/20Hz) at the points of PC6 (Neiguan) and PC4 (Ximen) from 30 min before anesthesia induction to the end of surgery, the optimal intensity will be adjusted to maintain a slight twitching of the midfinger or ring finger (De-Qi response). Patients in group C receive electrode plate at the same acupoints without any electrical stimulation. Heart rate variability will be collected on 1 day before surgery, 1, 3 and 5d after surgery. 3mL of venous blood will be collected before the induction of anesthesia, 1, 3 and 5d after surgery, the serum will be isolated for the measurement of serum concentration of high-sensitive troponin T (hs-cTnT)、CK、CRP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable angina pectoris\n* Slilent myocardial ischemia\n* Remote myocardial infarction\n\nExclusion Criteria:\n\n* Congenital heart disease\n* Have a history of cardiac surgery\n* Frequent ventricular / atrial premature beats, atrial fibrillation and other serious arrhythmia\n* Heart conduction diseases\n* Antiarrhythmic drugs used\n* Temporary and permanent pacemaker used\n* Intraoperative blood loss\\>800ml'}, 'identificationModule': {'nctId': 'NCT03418194', 'briefTitle': 'Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative HRV and Hs-cTnT of Elderly With CHD', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Third Hospital'}, 'officialTitle': 'Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative Heart Rate Variability and High-sensitive Cardiac Troponin of Elderly Patients With Coronary Heart Disease', 'orgStudyIdInfo': {'id': 'TAESOFLHZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAES group', 'description': 'Patients in group TAES group received transcutaneous acupoint electrical stimulation (disperse-dense waves, frequency 4/20Hz) at the points of PC6 (Neiguan) and PC4 (Ximen) from 30 min before anesthesia induction to the end of surgery,', 'interventionNames': ['Procedure: transcutaneous acupoint electrical stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Patients in group C received electrode plate atthe points of PC6 (Neiguan) and PC4 (Ximen) without any electrical stimulation.', 'interventionNames': ['Procedure: sham transcutaneous acupoint electrical stimulation']}], 'interventions': [{'name': 'transcutaneous acupoint electrical stimulation', 'type': 'PROCEDURE', 'description': 'Transcutaneous acupoint electrical stimulation(TAES) is a kind of noninvasive therapy similar to acupuncture and moxibustion. Its physiological effect is similar to that of electroacupuncture and hand acupuncture which is a Chinese traditonal therapy using acupuncture.', 'armGroupLabels': ['TAES group']}, {'name': 'sham transcutaneous acupoint electrical stimulation', 'type': 'PROCEDURE', 'description': 'Sham transcutaneous acupoint electrical stimulation is the same procedure as transcutaneous acupoint electrical stimulation at points without electronic stimulation.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050051', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Third Hospital of Hebei Medical Universit', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'overallOfficials': [{'name': 'Xiuli Wang, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Third Hospital of Hebei Medical Universit Department of Anesthesiology'}, {'name': 'Huizhou li, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Third Hospital of Hebei Medical Universit Department of Anesthesiology'}, {'name': 'Chuan Wu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Third Hospital of Hebei Medical Universit Department of Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}