Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 9:47 PM
Study NCT ID:
NCT03074604
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The CANON trial is designed as a randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms and a primary endpoint being the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New lesions on control brain magnetic resonance imaging.', 'timeFrame': '3 days after surgery', 'description': 'Appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.'}], 'secondaryOutcomes': [{'measure': 'New focal neurological deficits.', 'timeFrame': '7 days after surgery', 'description': 'Prevalence of new focal neurological deficits in the first 7 days after surgery.'}, {'measure': 'Occurence of postoperative cognitive dysfunction', 'timeFrame': '1 week or 3 months after surgery', 'description': 'Occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery'}, {'measure': 'Incidence of delirium', 'timeFrame': '7 days after surgery', 'description': 'Incidence of delirium in the first 7 days after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Injuries', 'Neurological Injury', 'Stroke', 'Postoperative Cognitive Dysfunction', 'Postoperative Delirium', 'Coronary Artery Disease', 'Coronary Artery Bypass Grafting', 'Coronary Artery Bypass Surgery', 'Bypass surgery', 'Beating Heart Coronary Artery Bypass', 'Off-Pump Coronary Artery Bypass'], 'conditions': ['Neurological Injury', 'Stroke', 'Postoperative Cognitive Dysfunction', 'Postoperative Delirium', 'Coronary Artery Disease', 'Coronary Artery Bypass Surgery', 'Off-Pump Coronary Artery Bypass']}, 'referencesModule': {'references': [{'pmid': '28698347', 'type': 'DERIVED', 'citation': 'Krzysztof S, Wojciech P, Zbigniew S, Mariusz K, Remigiusz T, Damian P, Magdalena S, Marta T, Lech A, Alina B. CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms. BMJ Open. 2017 Jul 10;7(7):e016785. doi: 10.1136/bmjopen-2017-016785.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the value of employing the aortic no-touch off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary revascularization.', 'detailedDescription': 'Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offset survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue, is off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques.\n\nIn this randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment and one control arms. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with a partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG. The primary endpoint will be the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective and/or urgent coronary artery bypass\n\nExclusion Criteria:\n\n* emergent and salvage setting\n* score below age- and education-adjusted cut-off scores in mini mental state examination\n* score above 8 on the subscales of hospital anxiety and depression scale\n* neurologic deficit of any etiology\n* previous psychiatric illness\n* use of tranquilizers or antipsychotics\n* alcohol or drug abuse\n* history of cardiac surgery\n* left ventricular ejection fraction less than 30%\n* extracranial carotid artery stenosis of more than 70%\n* body mass index of more than 35 kg/m2\n* any contraindication for magnetic resonance imaging (e.g., magnetic resonance imaging - incompatible implantable device and claustrophobia)'}, 'identificationModule': {'nctId': 'NCT03074604', 'acronym': 'CANON', 'briefTitle': 'Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms.', 'organization': {'class': 'OTHER', 'fullName': 'Collegium Medicum w Bydgoszczy'}, 'officialTitle': 'Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms.', 'orgStudyIdInfo': {'id': 'KB 60/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aortic no-touch OPCABG', 'description': 'aortic no-touch OPCABG', 'interventionNames': ['Procedure: aortic no-touch OPCABG']}, {'type': 'EXPERIMENTAL', 'label': 'OPCABG with partial clamp applying carbon dioxide', 'description': 'OPCABG with partial clamp applying carbon dioxide', 'interventionNames': ['Procedure: OPCABG with partial clamp applying carbon dioxide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OPCABG with partial clamp', 'description': 'OPCABG with partial clamp', 'interventionNames': ['Procedure: OPCABG with partial clamp']}], 'interventions': [{'name': 'aortic no-touch OPCABG', 'type': 'PROCEDURE', 'description': '(Study arm 1) In this intervention only the internal mammary artery grafts will be used (i.e. left internal mammary artery graft, right internal mammary artery graft, or a Y-graft that uses right internal mammary artery graft anastomosed onto left internal mammary artery graft to allow for a wide territory of myocardial revascularization). However, in the rare event that the aforementioned approach is insufficient to reach all target vessels, a reversed (great) saphenous vein graft may be used to extend the left internal mammary artery graft or the right internal mammary artery graft.', 'armGroupLabels': ['aortic no-touch OPCABG']}, {'name': 'OPCABG with partial clamp applying carbon dioxide', 'type': 'PROCEDURE', 'description': '(Study arm 2) In this intervention chest cavity will be insufflated with carbon dioxide at a flow above 5 l/min during the entire surgical procedure.', 'armGroupLabels': ['OPCABG with partial clamp applying carbon dioxide']}, {'name': 'OPCABG with partial clamp', 'type': 'PROCEDURE', 'description': '(Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp.', 'armGroupLabels': ['OPCABG with partial clamp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-001', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'overallOfficials': [{'name': 'Krzysztof Szwed, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland'}, {'name': 'Alina Borkowska, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Available without time limits.', 'ipdSharing': 'YES', 'description': 'The data that support the findings of this study are available from the corresponding author upon reasonable request.', 'accessCriteria': 'The data that support the findings of this study are available from the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Collegium Medicum w Bydgoszczy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Krzysztof Szwed', 'investigatorAffiliation': 'Collegium Medicum w Bydgoszczy'}}}}