Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT06791551
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2025-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgery: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-01-19', 'studyFirstSubmitQcDate': '2025-01-19', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of neurological complications 7 (± 3) days after cardiac surgery', 'timeFrame': 'From enrollment to the post-surgery within 7 (±3) days', 'description': 'Lethal or non lethal stroke, coma, or motor impairment; Cognitive impairment or delirium'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac surgery', 'cognitive function', 'stroke', 'delirium', 'non-invasive neuromodulation', 'Remote Ischemic Preconditioning'], 'conditions': ['Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '39051611', 'type': 'BACKGROUND', 'citation': "Goede LL, Oxenford S, Kroneberg D, Meyer GM, Rajamani N, Neudorfer C, Krause P, Lofredi R, Fox MD, Kuhn AA, Horn A. Linking Invasive and Noninvasive Brain Stimulation in Parkinson's Disease: A Randomized Trial. Mov Disord. 2024 Nov;39(11):1971-1981. doi: 10.1002/mds.29940. Epub 2024 Jul 25."}, {'pmid': '38635271', 'type': 'BACKGROUND', 'citation': 'Li C, Tao M, Chen D, Wei Q, Xiong X, Zhao W, Tan W, Yang J, Han Y, Zhang H, Zhang S, Liu H, Cao JL. Transcranial Direct Current Stimulation for Anxiety During Laparoscopic Colorectal Cancer Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e246589. doi: 10.1001/jamanetworkopen.2024.6589.'}, {'pmid': '38172875', 'type': 'BACKGROUND', 'citation': 'Law YM, Hsu C, Hingorani SR, Richards M, McMullan DM, Jefferies H, Himmelfarb J, Katz R. Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery. J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8.'}, {'pmid': '31142632', 'type': 'BACKGROUND', 'citation': 'Nyquist P, Georgakis MK. Remote ischemic preconditioning effects on brain vasculature. Neurology. 2019 Jul 2;93(1):15-16. doi: 10.1212/WNL.0000000000007724. Epub 2019 May 29. No abstract available.'}, {'pmid': '37951812', 'type': 'BACKGROUND', 'citation': 'Hardt JLS, Pohlmann P, Reissfelder C, Rahbari NN. Remote ischemic preconditioning for reduction of ischemia-reperfusion injury after hepatectomy: A randomized sham-controlled trial. Surgery. 2024 Feb;175(2):424-431. doi: 10.1016/j.surg.2023.09.042. Epub 2023 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. The goal of this clinical trial is to learn if ischemic preconditioning and transcranial electrical stimulation to reduce perioperative neurological complications. It will also learn about the safety of remote ischemic preconditioning and transcranial electrical stimulation before cardiac surgery. The main questions it aims to answer are "Do remote ischemic preconditioning and transcranial electrical stimulation make good effect on perioperative neurological complications?" "Are remote ischemic preconditioning and transcranial electrical stimulation safe?" Researchers will compare remote ischemic preconditioning and transcranial electrical stimulation to traditional treatment to see if remote ischemic preconditioning and transcranial electrical stimulation work to reduce perioperative neurological complications.\n\nParticipants will:Undergo remote ischemic preconditioning and transcranial electrical stimulation or sham treatment twice every day for 3 days before surgery.\n\nUndertake psychological assessment and clinical symptom follow-up after cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range: 18-80 years old;\n2. Surgical patients with heart disease;\n3. Elective surgery;\n4. Patients identified as high-risk for postoperative neurological complications; Previous stroke history; Moderate to severe stenosis of the head and neck arteries was evaluated;\n5. Be able to understand and comply with the requirements of clinical trial protocols, and voluntarily sign informed consent forms.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06791551', 'acronym': 'NICE', 'briefTitle': 'Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgery: a Randomized Controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgry: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024-2460-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active RIPC and tDCS', 'description': 'RIPC and tDCS twice every day for 3 days before cardiac surgery'}, {'type': 'SHAM_COMPARATOR', 'label': 'sham RIPC and tDCS', 'description': 'Sham RIPC and tDCS twice every day for 3 days before cardiac surgery', 'interventionNames': ['Device: Sham (No Treatment)']}], 'interventions': [{'name': 'active RIPC and tDCS', 'type': 'DEVICE', 'description': 'Preoperative use of a therapeutic device with sleeves fixed on the upper side of both arms, compressing the bilateral brachial arteries to 200mmHg for 5 minutes, resting for 5 minutes, repeating 5 times, recorded as 1 time, training once in the morning and afternoon each day, and continuing treatment for at least 3 days; Administer transcranial electrical stimulation, 2mA, 30min, for 3 days;'}, {'name': 'Sham (No Treatment)', 'type': 'DEVICE', 'description': 'received sham treatment with the same appearance instrument;', 'armGroupLabels': ['sham RIPC and tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yao Feng, M.D', 'role': 'CONTACT', 'email': 'fengyao_dr@sina.com', 'phone': '18810643595'}], 'facility': 'Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing,', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yao Feng, M.D.', 'role': 'CONTACT', 'email': 'fengyao_dr@sina.com', 'phone': '18810643595'}], 'overallOfficials': [{'name': 'Shujuan Li, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Shujuan Li', 'investigatorAffiliation': 'China National Center for Cardiovascular Diseases'}}}}