Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-30 @ 5:13 AM
Study NCT ID:
NCT07302659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of new-onset postoperative silent brain infarction (SBI)', 'timeFrame': 'Before postoperative discharge (approximately postoperative day 5)', 'description': 'Defined as newly developed cerebral infarctions identified on postoperative MRI, compared with the preoperative MRI, without any corresponding clinical signs or symptoms of cerebral infarction.'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative delirium', 'timeFrame': 'within 5 postoperative days', 'description': 'The incidence of delirium evaluated by CAM/CAM-ICU'}, {'measure': 'Perioperative major adverse cardiovascular and cerebrovascular events (MACCE)', 'timeFrame': 'within 30 postoperative days', 'description': 'Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.'}, {'measure': 'Six-month postoperative graft patency rate (assessed by coronary CT angiography)', 'timeFrame': '6 months after surgery'}, {'measure': 'MACCE within 6 months after surgery', 'timeFrame': '6 months after surgery', 'description': 'Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.'}, {'measure': 'Angina within 6 months after surgery', 'timeFrame': '6 months after surgery', 'description': 'Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 6 months post CABG'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery bypass graft', 'Silent Brain Infarction'], 'conditions': ['Coronary Artery Bypass Graft (CABG)']}, 'referencesModule': {'references': [{'pmid': '28231944', 'type': 'RESULT', 'citation': 'Zhao DF, Edelman JJ, Seco M, Bannon PG, Wilson MK, Byrom MJ, Thourani V, Lamy A, Taggart DP, Puskas JD, Vallely MP. Coronary Artery Bypass Grafting With and Without Manipulation of the Ascending Aorta: A Network Meta-Analysis. J Am Coll Cardiol. 2017 Feb 28;69(8):924-936. doi: 10.1016/j.jacc.2016.11.071.'}, {'pmid': '31735394', 'type': 'RESULT', 'citation': 'Tachibana H, Hiraoka A, Saito K, Naito Y, Chikazawa G, Tamura K, Totsugawa T, Yoshitaka H, Sakaguchi T. Incidence and impact of silent brain lesions after coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2021 Feb;161(2):636-644. doi: 10.1016/j.jtcvs.2019.09.162. Epub 2019 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'To explore surgical strategies that reduce perioperative neurologic complications in cardiovascular surgery, with the aim of improving perioperative outcomes and quality of life while reducing the socioeconomic burden. Specifically:\n\nThis multicenter, randomized controlled clinical trial will evaluate the benefits of a novel aortic no-touch technique in reducing perioperative silent brain infarction(SBI) among patients undergoing surgical treatment for coronary artery disease. The findings are expected to provide a safe and effective myocardial revascularization strategy for individuals at high risk of cerebral ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18 years old) with multivessel coronary artery disease who are scheduled to undergo isolated off-pump coronary artery bypass grafting and who provide informed consent to participate in this study.\n\nExclusion Criteria:\n\n* Indications for cardiopulmonary bypass surgery (or no contraindications to on-pump surgery);\n* Great saphenous vein is unsuitable for use as a graft conduit;\n* Subclavian artery stenosis or occlusion, or any contraindication to the use of the internal mammary artery as a graft conduit;\n* History of previous cardiac surgery;\n* Emergency surgery.'}, 'identificationModule': {'nctId': 'NCT07302659', 'acronym': 'PROTECT-CABG', 'briefTitle': 'Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': '2023ZD0504701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Traditional off-pump coronary artery bypass grafting (TA-SVG)'}, {'type': 'EXPERIMENTAL', 'label': 'Aortic no-touch coronary artery bypass grafting (RIMA-SVG)', 'interventionNames': ['Procedure: Aortic no-touch coronary artery bypass grafting (RIMA-SVG)']}], 'interventions': [{'name': 'Aortic no-touch coronary artery bypass grafting (RIMA-SVG)', 'type': 'PROCEDURE', 'description': 'Ascending aortic no-touch CABG with saphenous vein graft (SVG) anastomosed to the right internal mammary artery (RIMA)', 'armGroupLabels': ['Aortic no-touch coronary artery bypass grafting (RIMA-SVG)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Chen', 'role': 'CONTACT', 'email': 'chenlianx1@163.com', 'phone': '01088322265'}], 'facility': 'Fuwai Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Wang', 'role': 'CONTACT', 'email': 'wj0463@sina.cn', 'phone': '+86 13522784537'}], 'facility': 'Peking University First Hospita', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Qingdao', 'country': 'China', 'contacts': [{'name': 'Feng', 'role': 'CONTACT', 'email': 'fengzunyi@163.com', 'phone': '+86 13964265680'}], 'facility': 'Qingdao Cardiovascular Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shenzhen', 'country': 'China', 'contacts': [{'name': 'Nie', 'role': 'CONTACT', 'email': 'wangsymd@126.com', 'phone': '+86 13701176101'}], 'facility': 'Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Lianxin Chen', 'role': 'CONTACT', 'email': 'chenlianx1@163.com', 'phone': '01088322265'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}