Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-01 @ 1:56 AM
Study NCT ID:
NCT07116733
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desflurane vs. Propofol for Cardiac Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3560}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SOFA score', 'timeFrame': 'during postoperative ICU stay, with an average of 10 days', 'description': 'Daily SOFA scores during ICU stay'}, {'measure': 'The need for blood product transfusions', 'timeFrame': 'from the day of surgery to hospital discharge, average for 7-10 days', 'description': 'The volume of RBCs, Platelet, FFP transfusion'}, {'measure': 'Volume of chest tube drainage', 'timeFrame': 'within 72 hours following surgery'}, {'measure': 'Requirement for vasoactive agents support for more than 48 hours', 'timeFrame': 'at 48 hours following surgery'}, {'measure': 'The maximum VIS (Vasoactive-Inotropes Score)', 'timeFrame': 'within 7 days following surgery'}, {'measure': 'incidence of postoperative infection', 'timeFrame': 'from end of surgery until hospital discharge, average for 10 days', 'description': 'including pneumonia, deep sternal wound infection/mediastinitis, endocarditis, central venous catheter-related infection, urinary tract infection'}, {'measure': 'the Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'at 90 days and 1 years following surgery', 'description': 'KCCQ measures symptoms, physical and social limitations, and quality of life in patients with heart failure'}], 'primaryOutcomes': [{'measure': 'Composite outcome of death and major cardiac events', 'timeFrame': 'within 30 days after operation', 'description': 'It is composite outcome including:\n\n1. All-cause mortality within 30 days postoperatively\n2. New-onset acute heart failure, or any of the following: Cardiac arrest with successful resuscitation; Cardiogenic shock requiring mechanical circulatory support: Intra-aortic balloon pump (IABP), Extracorporeal membrane oxygenation (ECMO), Left ventricular assist device (e.g., Impella); Low cardiac output syndrome necessitating high-dose inotropic support (Inotropic Score (IS) \\>15 within the first 24 postoperative hours, IS \\>10 within 48 postoperative hours).\n3. Arrhythmia requiring intervention: New-onset atrial fibrillation (pharmacotherapy or pacemaker),Other clinically significant arrhythmias.\n4. Acute myocardial infarction\n5. Emergency sternotomy/re-exploration for: Cardiac tamponade, Uncontrolled hemorrhage, Other life-threatening complications.'}], 'secondaryOutcomes': [{'measure': 'Incidence of death and the major cardiac events', 'timeFrame': 'within 30 days after operation', 'description': 'the incidence of each component outcome in the primary outcome'}, {'measure': 'Total number of death and major cardiac events', 'timeFrame': 'within 30 days after operation', 'description': 'Total number of events listed as the components of the primary outcomes.'}, {'measure': 'Length of mechanical ventilation', 'timeFrame': 'within 30 days after operation', 'description': 'Length of mechanical ventilation in hours'}, {'measure': 'Length of lCU stay', 'timeFrame': 'From the date of surgery until the date patient discharge from hospital, assessed up to 1 year', 'description': 'Length of postoperative lCU stay'}, {'measure': 'Incidence of pulmonary complications', 'timeFrame': 'within 30 days after operation', 'description': 'Including pulmonary infection, pleural effusion, respiratory failure, acute respiratory distress syndrome, pneumothorax, pulmonary embolism'}, {'measure': 'Incidence of renal complications', 'timeFrame': 'within 30 days after operation', 'description': 'Including AKI and RRT'}, {'measure': 'Incidence of neurological complications', 'timeFrame': 'within 30 days after operation', 'description': 'Including delirium, stroke, cognitive impairment'}, {'measure': 'Readmission', 'timeFrame': 'within 30 days after operation', 'description': 'Readmission after hospital discharge'}, {'measure': 'All cause 90 d mortality', 'timeFrame': 'within 90 davs after operation', 'description': 'Death within 90 days after surgery for any reason'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Desflurane', 'Propofol', 'Cardiac Surgery', 'Major Cardiac Event', 'Coronary Artery Bypass Grafting'], 'conditions': ['Cardiac Surgery', 'Coronary Artery Bypass Grafting']}, 'referencesModule': {'references': [{'pmid': '38774674', 'type': 'BACKGROUND', 'citation': 'Kampman JM, Hermanides J, Hollmann MW, Gilhuis CN, Bloem WA, Schraag S, Pradelli L, Repping S, Sperna Weiland NH. Mortality and morbidity after total intravenous anaesthesia versus inhalational anaesthesia: a systematic review and meta-analysis. EClinicalMedicine. 2024 May 14;72:102636. doi: 10.1016/j.eclinm.2024.102636. eCollection 2024 Jun.'}, {'pmid': '37405905', 'type': 'BACKGROUND', 'citation': 'Qin H, Zhou J. Myocardial Protection by Desflurane: From Basic Mechanisms to Clinical Applications. J Cardiovasc Pharmacol. 2023 Sep 1;82(3):169-179. doi: 10.1097/FJC.0000000000001448.'}, {'pmid': '35168907', 'type': 'BACKGROUND', 'citation': 'Zangrillo A, Lomivorotov VV, Pasyuga VV, Belletti A, Gazivoda G, Monaco F, Nigro Neto C, Likhvantsev VV, Bradic N, Lozovskiy A, Lei C, Bukamal NAR, Silva FS, Bautin AE, Ma J, Yong CY, Carollo C, Kunstyr J, Wang CY, Grigoryev EV, Riha H, Wang C, El-Tahan MR, Scandroglio AM, Mansor M, Lembo R, Ponomarev DN, Bezerra FJL, Ruggeri L, Chernyavskiy AM, Xu J, Tarasov DG, Navalesi P, Yavorovskiy A, Bove T, Kuzovlev A, Hajjar LA, Landoni G; MYRIAD Study Group. Effect of Volatile Anesthetics on Myocardial Infarction After Coronary Artery Surgery: A Post Hoc Analysis of a Randomized Trial. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2454-2462. doi: 10.1053/j.jvca.2022.01.001. Epub 2022 Jan 7.'}, {'pmid': '30888743', 'type': 'BACKGROUND', 'citation': 'Landoni G, Lomivorotov VV, Nigro Neto C, Monaco F, Pasyuga VV, Bradic N, Lembo R, Gazivoda G, Likhvantsev VV, Lei C, Lozovskiy A, Di Tomasso N, Bukamal NAR, Silva FS, Bautin AE, Ma J, Crivellari M, Farag AMGA, Uvaliev NS, Carollo C, Pieri M, Kunstyr J, Wang CY, Belletti A, Hajjar LA, Grigoryev EV, Agro FE, Riha H, El-Tahan MR, Scandroglio AM, Elnakera AM, Baiocchi M, Navalesi P, Shmyrev VA, Severi L, Hegazy MA, Crescenzi G, Ponomarev DN, Brazzi L, Arnoni R, Tarasov DG, Jovic M, Calabro MG, Bove T, Bellomo R, Zangrillo A; MYRIAD Study Group. Volatile Anesthetics versus Total Intravenous Anesthesia for Cardiac Surgery. N Engl J Med. 2019 Mar 28;380(13):1214-1225. doi: 10.1056/NEJMoa1816476. Epub 2019 Mar 19.'}, {'pmid': '37919165', 'type': 'BACKGROUND', 'citation': 'Han J, Ryu JH, Jeon YT, Koo CH. Comparison of Volatile Anesthetics Versus Propofol on Postoperative Cognitive Function After Cardiac Surgery: A Systematic Review and Meta-analysis. J Cardiothorac Vasc Anesth. 2024 Jan;38(1):141-147. doi: 10.1053/j.jvca.2023.09.038. Epub 2023 Oct 2.'}, {'pmid': '36301724', 'type': 'BACKGROUND', 'citation': 'Jiang JL, Zhang L, He LL, Yu H, Li XF, Dai SH, Yu H. Volatile Versus Total Intravenous Anesthesia on Postoperative Delirium in Adult Patients Undergoing Cardiac Valve Surgery: A Randomized Clinical Trial. Anesth Analg. 2023 Jan 1;136(1):60-69. doi: 10.1213/ANE.0000000000006257. Epub 2022 Oct 27.'}, {'pmid': '32205551', 'type': 'BACKGROUND', 'citation': 'Bonanni A, Signori A, Alicino C, Mannucci I, Grasso MA, Martinelli L, Deferrari G. Volatile Anesthetics versus Propofol for Cardiac Surgery with Cardiopulmonary Bypass: Meta-analysis of Randomized Trials. Anesthesiology. 2020 Jun;132(6):1429-1446. doi: 10.1097/ALN.0000000000003236.'}, {'pmid': '30165632', 'type': 'BACKGROUND', 'citation': 'Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):4-90. doi: 10.1093/ejcts/ezy289. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether the inhaled anesthetic desflurane, compared with propofol, exerts cardioprotective effects and reduces the incidence of severe postoperative major cardiac events in patients undergoing coronary artery bypass graft (CABG) surgery.', 'detailedDescription': "Cardiac surgery is among the highest-risk surgical procedures, with a high incidence of severe postoperative complications that affect patient prognosis. It is a critical factor significantly increasing perioperative mortality and poses a major challenge to the prognosis of patients undergoing cardiac surgery. Coronary-artery bypass grafting (CABG) is the most common cardiac surgery, with over 300,000 procedures performed annually in the United States alone. The incidence of cardiac complications after cardiac surgery is as high as 50%, including approximately 35% for new-onset atrial fibrillation, 30% for acute kidney injury, 16% for respiratory failure, 5% for severe infection, and an in-hospital mortality rate of about 3.5%. Key pathogenic factors contributing to severe complications after cardiac surgery include surgical stress responses, insufficient organ perfusion during perioperative management, and tissue/organ damage or dysfunction caused by oxidative stress responses induced by the release of inflammatory factors.\n\nOutcomes and prognosis following cardiac surgery are influenced by patient characteristics, surgical techniques, and perioperative management. Over the years, we have continuously sought to develop effective strategies to reduce the incidence of perioperative complications and mortality. Anesthesia for CABG (Coronary Artery Bypass Graft) is typically induced solely with intravenous agents (Total Intravenous Anesthesia - TIVA) or using a combination of volatile (inhaled) and intravenous agents. When administered prior to, during, or after an ischemic event, volatile anesthetics exert cytoprotective effects via multiple mechanisms. These include modulating G protein-coupled receptors, intracellular signaling pathways, gene expression, potassium channels, and mitochondrial function . Furthermore, volatile anesthetics reduce myocardial infarct size in animal models. Several randomized controlled trials (RCTs) suggest volatile anesthetics can reduce biomarkers of myocardial injury, even when administered for only a brief period before ischemia. Additionally, inhaled anesthetics , besides reducing postoperative cardiac troponin release and preserving cardiac function after cardiac surgery, may also lower the risk of myocardial infarction .\n\nHowever, the impact of volatile anesthetics on postoperative complications and mortality following cardiac surgery remains inconsistent. Some meta-analyses have demonstrated reduced mortality after CABG with volatile anesthetics, a finding consistent with observations from moderate-sized randomized controlled trials. Two international consensus conferences identified volatile anesthetics as key non-surgical interventions to improve survival in patients undergoing major surgery, with potential significant clinical implications for over 300 million surgical patients annually. Guidelines from the American College of Cardiology, American Heart Association, and European Association for Cardio-Thoracic Surgery recommend applying these findings to anesthetic management in cardiac surgery patients, advocating inhalational anesthetics for maintenance in patients at cardiovascular risk to reduce postoperative complications. However, other randomized controlled trials and meta-analyses have failed to confirm such benefits. Conflicting results also exist regarding postoperative complications, including pulmonary complications, neurocognitive disorders, and renal injury.\n\nThe large-scale international multicenter Myriad trial-designed to enroll 10,600 patients undergoing isolated CABG to compare inhalational anesthetics (isoflurane, sevoflurane, or desflurane) versus intravenous propofol on postoperative mortality-the study was prematurely terminated for futility after enrolling 5,400 CABG cases. Interim analysis revealed no differences in 30-day and 1-year all-cause mortality between volatile anesthesia and total intravenous anesthesia (TIVA) groups. Another multicenter study (Br J Anaesth. 2024 Aug;133(2):296-304), involving 3,123 cardiac surgery patients across 16 Chinese centers, compared inhalational (sevoflurane/desflurane) and intravenous (propofol) anesthesia for composite outcomes including 30-day all-cause mortality and severe organ complications. No significant difference was observed: 33.8% in the inhalational group versus 33.2% in the intravenous group (adjusted OR 1.05, 95% CI 0.90-1.22; P=0.57).\n\nDesflurane , introduced into clinical practice in 1990 as an inhaled anesthetic, is characterized by rapid induction and recovery , contributing to reduced postoperative recovery-related complications . Studies confirm that desflurane anesthesia lowers the surgical stress response , aiding in the maintenance of hemodynamic stability . Furthermore, multiple studies have found that compared to intravenous anesthesia, desflurane offers superior myocardial protection for CABG patients, reducing pulmonary complications, shortening hospital stays, lowering mortality, and improving quality of life . Its mechanisms may relate to its effects on mitochondrial permeability transition pore, mitochondrial electron transport chain, reactive oxygen species, ATP-sensitive potassium channels, G protein-coupled receptors, and protein kinase C biological functions. In non-cardiac surgery, desflurane did not reduce postoperative respiratory complications compared to sevoflurane . Although clinical evidence supporting the beneficial effects of inhaled anesthetics, particularly desflurane, in cardiac surgery patients is limited and insufficient , they do highlight its potential advantages . Research into desflurane's optimal administration method and dosage , as well as its long-term effects , is ongoing.\n\nA recently published Meta-analysis indicated that, compared to propofol , desflurane demonstrated potential clinical benefit for surgical patients in terms of 30-day mortality, incidence of myocardial infarction, new-onset postoperative atrial fibrillation, postoperative pneumonia, and atelectasis . However, these findings stemmed from small sample sizes and underpowered studies .\n\nBased on the available evidence, the inconsistent conclusions across current studies may stem from :\n\n1. Differential organ-specific effects of inhalational versus intravenous anesthetics: Inhalational agents confer significant cardiovascular benefits, whereas intravenous agents offer neurological advantages. Consequently, using mortality or composite outcomes encompassing severe complications across all organ systems as primary endpoints leads to confounding of divergent effects, posing challenges for result interpretation and clinical practice guidance.\n2. Heterogeneity in cardioprotective efficacy among inhalational agents: Existing studies have not restricted the type of inhalational anesthetics used. When compared to the intravenous agent propofol, commonly used inhalational anesthetics (isoflurane, desflurane, sevoflurane) exhibit heterogeneous cardioprotective effects: isoflurane shows weaker cardioprotection than propofol; sevoflurane demonstrates no significant difference; and desflurane exhibits stronger cardioprotection than propofol.\n3. Impact of timing and duration of inhalational anesthetic administration: In clinical practice, the timing and duration of inhalational agent use influence their cardioprotective efficacy, representing a key source of effect heterogeneity across studies.\n\nTo date, no study has provided robust evidence supporting a preferred anesthesia regimen or agent for preventing severe complications and reducing mortality after cardiac surgery. Building upon the potential advantages of desflurane in myocardial protection and improving postoperative survival , identified in preliminary small-scale studies or exploratory analyses of other large trials , we plan to initiate a large-scale, national, multi-center randomized clinical trial (DECIDE-CABG trial) .\n\nThis trial will enroll 3,560 elective patients undergoing isolated CABG to compare the impact of desflurane-based inhaled anesthesia maintenance versus propofol-based TIVA maintenance on the incidence of major adverse cardiovascular events (MACE) and all-cause mortality at 30 days postoperatively . Through this large-scale, multi-center, randomized controlled study , we aim to definitively identify the optimal anesthesia regimen and anesthetic agents for CABG patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients scheduled for elective coronary artery bypass grafting (CABG)\n2. Age ≥ 18 years old;\n3. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. Emergency or urgent operation\n2. Concomitant valve or aortic surgery\n3. History of myocardial infarction in recent 30 days\n4. Current use of myocardial preconditioning-affecting medications, such as sulfonylurea (glibenclamide), allopurinol, theophylline, nicorandil(last dose \\< 8 hrs), etc\n5. Participated in other randomized controlled clinical trials in recent 3 months\n6. General anesthesia in recent 30 days\n7. History of kidney and liver transplantation, or severe liver and kidney dysfunction (EGFR ≤ 20 mlgmin/1.73 m2, conventional dialysis or patients who have started dialysis; Child Pugh grade C/cirrhosis)\n8. History of open heart surgery;\n9. Hemodynamic instability or severe heart failure (SBP\\<90 mmHg or preoperative need of high-dose vasoactive drug support, placement of aortic balloon pump (IABP), ECMO or ventricular assist device, left ventricular ejection fraction\\<30%)\n10. Adverse drug reactions to trial medications\n11. History of malignant hyperthermia\n12. Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT07116733', 'acronym': 'DECIDE-CABG', 'briefTitle': 'Desflurane vs. Propofol for Cardiac Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Desflurane vs. Propofol for Cardiac Anesthesia: Impact on Developing Major Cardiac Events in Patients Undergoing CABG Procedure', 'orgStudyIdInfo': {'id': 'KY20250104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desflurane group', 'description': 'After routine induction, anesthesia is maintained with inhaled desflurane, with the concentration adjusted as needed to maintain 0.5-2 MAC .Propofol is not used to maintain anesthesia during the whole anesthesia maintenance process, except during cardiopulmonary bypass.', 'interventionNames': ['Drug: Desflurane group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': '3-8 mg/kg/h intravenous infusion of propofol to implement total intravenous anesthesia maintenance, without the use of any inhaled anesthetic drugs, can be maintained by intravenous targeted infusion or manual adjustment of intravenous infusion.', 'interventionNames': ['Drug: Propofol group']}], 'interventions': [{'name': 'Desflurane group', 'type': 'DRUG', 'description': 'After routine induction, maintain anesthesia with inhaled desflurane , adjusting concentration as needed to sustain 0.5-2 MAC . To maximize the cardioprotective effects of inhaled anesthetics, adhere to this intraoperative strategy:\n\nMaintain ≥1 MAC continuous desflurane for ≥30 minutes ; For on-pump CABG , discontinue desflurane 15 minutes before initiating cardiopulmonary bypass (CPB) ;\n\nIf intraoperative desflurane cessation is required, implement a wash-in/wash-out strategy (recommended but non-mandatory):\n\nPerform 3 alternating cycles of:\n\nWash-in : ≥10 minutes of desflurane at ≥0.5 MAC, Wash-out : ≥10 minutes of complete cessation of inhaled anesthetics. Propofol is strictly prohibited for anesthesia maintenance throughout the procedure , except during CPB.', 'armGroupLabels': ['Desflurane group']}, {'name': 'Propofol group', 'type': 'DRUG', 'description': 'Administer total intravenous anesthesia (TIVA) using propofol infusion at 3-8 mg/kg/h . No inhaled anesthetics are permitted for maintenance. This may be delivered via:target-controlled infusion (TCI) systems, or manual adjustment of intravenous infusion rates.', 'armGroupLabels': ['Propofol group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lihua LEI, M.D.', 'role': 'CONTACT', 'email': 'mzkleilihua@163.com', 'phone': '86-13705045270'}], 'facility': 'Fuzhou University Affiliated Provincial Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Cangzhou', 'state': 'Hebei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Airong Zhang, M.D.', 'role': 'CONTACT', 'email': 'Zhangairong66@sohu.com', 'phone': '86-13582711769'}], 'facility': "Cangzhou People's Hospital", 'geoPoint': {'lat': 38.31124, 'lon': 116.85334}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianli Li, M.D.', 'role': 'CONTACT', 'email': 'hblijianli@163.com', 'phone': '86-13785118676'}], 'facility': 'Hebei General Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Wang, M.D.', 'role': 'CONTACT', 'email': 'lw79812@163.com', 'phone': '86-13933170139'}], 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Li, M.D.', 'role': 'CONTACT', 'email': 'li6121@163.com', 'phone': '86-13676964593'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiqin Huang, M.D.', 'role': 'CONTACT', 'email': 'hwq2010@139.com', 'phone': '86-13986115788'}], 'facility': 'Wuhan Asia Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanjin', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Chen, M.D.', 'role': 'CONTACT', 'email': 'chenyu020219@163.com', 'phone': '86-1351033928'}], 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 31.75772, 'lon': 121.74055}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chong Lei, M.D. & phD', 'role': 'CONTACT', 'email': 'crystalleichong@126.com', 'phone': '86-18629011362'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian LEI, M.D.', 'role': 'CONTACT', 'email': 'leiqianggh@163.com', 'phone': '86-17744339891'}], 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiange Han, M.D.', 'role': 'CONTACT', 'email': 'hanjiange@163.com', 'phone': '+86-13821001156'}], 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junpin Chen, M.D.', 'role': 'CONTACT', 'email': '13858222873@163.com', 'phone': '86-13858222873'}], 'facility': 'Ningbo No.2 Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Chongqing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingxiang MAO, M.D.', 'role': 'CONTACT', 'email': 'qxmao@tmmu.edu.cn', 'phone': '86-13594054231'}], 'facility': 'Daping Hospital, Army Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rui BAO, M.D.', 'role': 'CONTACT', 'email': 'baorui_md@163.com', 'phone': '86-13816947847'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kefang Guo, M.D.', 'role': 'CONTACT', 'email': 'dr_guokefang@163.com', 'phone': '86-13817706936'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Chong Lei, M.D.& phd', 'role': 'CONTACT', 'email': 'crystalleichong@126.com', 'phone': '18629011362'}], 'overallOfficials': [{'name': 'Chong Lei, M.D., phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'beginning 12 morths after publication of the primary results', 'ipdSharing': 'YES', 'description': 'The sharing ofindividual Patient Data (lPD) will be considered at 1 year after the publication ofthe primary resultsf the project. Any request for lPD sharing Investigator (Pl), clearly outlining the intended use of the data.should be submitted as a proposal to the Pl, clearly outlining the intended use of the data', 'accessCriteria': 'Investigators who provide a methodologically sound proposal and whose proposed use of data has been approved by the steering committee. For instance for using lPD data for meta- analysis. Proposals sholId be submitted to principle investigator and committee the trial. To gain access, data requestors will need to sign a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Chief of Anesthesia Clinical Research Center, Xijing Hospitall', 'investigatorFullName': 'Chong Lei, MD & phD', 'investigatorAffiliation': 'Xijing Hospital'}}}}