Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 12:25 PM
Study NCT ID:
NCT01842568
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15989}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2013-04-17', 'studyFirstSubmitQcDate': '2013-04-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality at 30-days after surgery', 'timeFrame': '30 days after surgery', 'description': 'All-cause mortality at 30-days after surgery'}, {'measure': 'Myocardial injuries that were not identified clinically during the first 5 days after surgery', 'timeFrame': '5 days after surgery', 'description': 'Myocardial injuries that were not identified clinically during the first 5 days after surgery'}, {'measure': 'Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device', 'timeFrame': '30 days after surgery', 'description': 'Major vascular complications at 30 days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device)'}, {'measure': 'Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device', 'timeFrame': '1 year after surgery', 'description': 'Major vascular complications at 1-year after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device)'}], 'secondaryOutcomes': [{'measure': 'Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device', 'timeFrame': '30 days after surgery', 'description': 'Major vascular complications at 30-days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device)'}, {'measure': 'Total mortality', 'timeFrame': '30 days after surgery', 'description': 'Total mortality'}, {'measure': 'Total mortality', 'timeFrame': '1 year after surgery', 'description': 'Total mortality'}, {'measure': 'Vascular mortality', 'timeFrame': '30 days after surgery', 'description': 'death due to vascular cause'}, {'measure': 'Vascular mortality', 'timeFrame': '1 year after surgery', 'description': 'death due to vascular cause'}, {'measure': 'Myocardial infarction', 'timeFrame': '30 days after surgery', 'description': 'Myocardial infarction'}, {'measure': 'Myocardial infarction', 'timeFrame': '1 year after surgery', 'description': 'Myocardial infarction'}, {'measure': 'Non-fatal cardiac arrest', 'timeFrame': '30 days after surgery', 'description': 'Non-fatal cardiac arrest'}, {'measure': 'Non-fatal cardiac arrest', 'timeFrame': '1 year after surgery', 'description': 'Non-fatal cardiac arrest'}, {'measure': 'Stroke', 'timeFrame': '30 days after surgery', 'description': 'Stroke'}, {'measure': 'Stroke', 'timeFrame': '1 year after surgery', 'description': 'Stroke'}, {'measure': 'Implantation of mechanical assist device', 'timeFrame': '30 days after surgery', 'description': 'Implantation of mechanical assist device'}, {'measure': 'Implantation of mechanical assist device', 'timeFrame': '1 year after surgery', 'description': 'Implantation of mechanical assist device'}, {'measure': 'Cardiac transplant', 'timeFrame': '30 days after surgery', 'description': 'Cardiac transplant'}, {'measure': 'Cardiac transplant', 'timeFrame': '1 year after surgery', 'description': 'Cardiac transplant'}, {'measure': 'Repeat cardiac revascularization procedures', 'timeFrame': '30 days after surgery', 'description': 'Repeat cardiac revascularization procedures'}, {'measure': 'Repeat cardiac revascularization procedures', 'timeFrame': '1 year after surgery', 'description': 'Repeat cardiac revascularization procedures'}, {'measure': 'Congestive heart failure', 'timeFrame': '30 days after surgery', 'description': 'Congestive heart failure'}, {'measure': 'Congestive heart failure', 'timeFrame': '1 year after surgery', 'description': 'Congestive heart failure'}, {'measure': 'New atrial fibrillation', 'timeFrame': '30 days after surgery', 'description': 'New clinically important atrial fibrillation'}, {'measure': 'New atrial fibrillation', 'timeFrame': '1 year after surgery', 'description': 'New clinically important atrial fibrillation'}, {'measure': 'Pulmonary embolus', 'timeFrame': '30 days after surgery', 'description': 'Pulmonary embolus'}, {'measure': 'Pulmonary embolus', 'timeFrame': '1 year after surgery', 'description': 'Pulmonary embolus'}, {'measure': 'Deep venous thrombosis', 'timeFrame': '30 days after surgery', 'description': 'Deep venous thrombosis'}, {'measure': 'Deep venous thrombosis', 'timeFrame': '1 year after surgery', 'description': 'Deep venous thrombosis'}, {'measure': 'Major bleeding', 'timeFrame': '30 days after surgery', 'description': 'Major bleeding'}, {'measure': 'Major bleeding', 'timeFrame': '1 year after surgery', 'description': 'Major bleeding'}, {'measure': 'New dialysis', 'timeFrame': '30 days after surgery', 'description': 'New dialysis'}, {'measure': 'New dialysis', 'timeFrame': '1 year after surgery', 'description': 'New dialysis'}, {'measure': 'Infection', 'timeFrame': '30 days after surgery', 'description': 'Infection (including sternal, sepsis, pneumonia)'}, {'measure': 'Infection', 'timeFrame': '1 year after surgery', 'description': 'Infection (including sternal, sepsis, pneumonia)'}, {'measure': 'Re-hospitalization for a vascular reason', 'timeFrame': '30 days after surgery', 'description': 'Re-hospitalization for a vascular reason'}, {'measure': 'Re-hospitalization for a vascular reason', 'timeFrame': '1 year after surgery', 'description': 'Re-hospitalization for a vascular reason'}, {'measure': 'Chronic incisional pain', 'timeFrame': '30 days after surgery', 'description': 'Chronic incisional pain'}, {'measure': 'Chronic incisional pain', 'timeFrame': '1 year after surgery', 'description': 'Chronic incisional pain'}, {'measure': 'Frailty', 'timeFrame': '30 days after surgery', 'description': 'Frailty assessed by PRISMA-7 questionnaire'}, {'measure': 'Frailty', 'timeFrame': '1 year after surgery', 'description': 'Frailty assessed by PRISMA-7 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac surgery', 'Troponin', 'Vascular events', 'Myocardial injury', 'Observational cohort study', 'Public health'], 'conditions': ['Vascular Death', 'Myocardial Infarction', 'Stroke', 'Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '35235725', 'type': 'DERIVED', 'citation': "Devereaux PJ, Lamy A, Chan MTV, Allard RV, Lomivorotov VV, Landoni G, Zheng H, Paparella D, McGillion MH, Belley-Cote EP, Parlow JL, Underwood MJ, Wang CY, Dvirnik N, Abubakirov M, Fominskiy E, Choi S, Fremes S, Monaco F, Urrutia G, Maestre M, Hajjar LA, Hillis GS, Mills NL, Margari V, Mills JD, Billing JS, Methangkool E, Polanczyk CA, Sant'Anna R, Shukevich D, Conen D, Kavsak PA, McQueen MJ, Brady K, Spence J, Le Manach Y, Mian R, Lee SF, Bangdiwala SI, Hussain S, Borges FK, Pettit S, Vincent J, Guyatt GH, Yusuf S, Alpert JS, White HD, Whitlock RP; VISION Cardiac Surgery Investigators. High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality. N Engl J Med. 2022 Mar 3;386(9):827-836. doi: 10.1056/NEJMoa2000803."}, {'pmid': '34330417', 'type': 'DERIVED', 'citation': 'Spence J, Bosch J, Chongsi E, Lee SF, Thabane L, Mendoza P, Belley-Cote E, Whitlock R, Brady K, McIntyre WF, Lamy A, Devereaux PJ. Standardized Assessment of Global activities in the Elderly scale in adult cardiac surgery patients. Br J Anaesth. 2021 Oct;127(4):539-546. doi: 10.1016/j.bja.2021.05.037. Epub 2021 Jul 28.'}, {'pmid': '30826789', 'type': 'DERIVED', 'citation': 'McGillion MH, Henry S, Busse JW, Ouellette C, Katz J, Choiniere M, Lamy A, Whitlock R, Pettit S, Hare J, Gregus K, Brady K, Dvirnik N, Yang SS, Parlow J, Dumerton-Shore D, Gilron I, Buckley DN, Shanthanna H, Carroll SL, Coyte PC, Ebrahim S, Isaranuwatchai W, Guerriere DN, Hoch J, Khan J, MacDermid J, Martorella G, Victor JC, Watt-Watson J, Howard-Quijano K, Mahajan A, Chan MTV, Clarke H, Devereaux PJ. Examination of psychological risk factors for chronic pain following cardiac surgery: protocol for a prospective observational study. BMJ Open. 2019 Mar 1;9(2):e022995. doi: 10.1136/bmjopen-2018-022995.'}, {'pmid': '30686303', 'type': 'DERIVED', 'citation': 'Ackland GL, Abbott TEF, Cain D, Edwards MR, Sultan P, Karmali SN, Fowler AJ, Whittle JR, MacDonald NJ, Reyes A, Paredes LG, Stephens RCM, Del Arroyo AG, Woldman S, Archbold RA, Wragg A, Kam E, Ahmad T, Khan AW, Niebrzegowska E, Pearse RM. Preoperative systemic inflammation and perioperative myocardial injury: prospective observational multicentre cohort study of patients undergoing non-cardiac surgery. Br J Anaesth. 2019 Feb;122(2):180-187. doi: 10.1016/j.bja.2018.09.002. Epub 2018 Oct 2.'}]}, 'descriptionModule': {'briefSummary': 'Worldwide over 2 million adults (\\>30,000 Canadians) undergo heart surgery annually. Although heart surgery provides important survival benefits, it is associated with potential major complications such as death, stroke, and heart attack. There is promising evidence that measurement of heart injury markers after surgery will identify patients at risk of death or major complications.\n\nThis study will determine the current incidence of major complications in a representative sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current burden of complications will inform clinicians, administrators, government and granting agencies about resources required to address the problem. This study will also establish the role of measuring heart injury markers to identify important heart injury after heart surgery and the proportion that would go undetected without routine heart injury marker monitoring. This information will facilitate further studies of timely interventions. In summary, the VISION Cardiac Surgery Study addresses fundamental questions that will have profound public health implications given the millions of adults worldwide who undergo heart surgery annually.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have undergone cardiac surgery who are at least 18 years of age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients who have undergone cardiac surgery. This includes coronary artery bypass grafting and all open heart procedures such as valvular repairs/replacement.\n\nExclusion Criteria:\n\n1. Previously enrolled in the VISION Cardiac Surgery Study.\n2. Patients who have undergone an isolated pericardial window, pericardiectomy, permanent pacemaker or defibrillator implantation.'}, 'identificationModule': {'nctId': 'NCT01842568', 'briefTitle': 'Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery', 'orgStudyIdInfo': {'id': 'VISION Cardiac Surgery'}}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan Medical Centre, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre - HCPA', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90620-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia do RS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '05403-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'INCOR', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Xinjiang', 'country': 'China', 'facility': 'First Teaching Hospital', 'geoPoint': {'lat': 30.46809, 'lon': 120.44325}}, {'zip': 'NT', 'city': 'Shatin', 'state': 'Hong Kong, SAR', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Santa Maria Hospital, GVM Care and Research', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'University of Bari "Aldo Moro"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '50400', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Institut Jantung Negara Sdn. Bhd.', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University of Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '80-211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Department of Cardiovascular Surgery, Medical University of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '650002', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Federal State Budgetary Institution "Research Institute for Complex Issues of Cardiovascular Diseases"', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '630055', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Essex Cardiothoracic Centre, Basildon and Thurrock University NHS Trust', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'Blackpool Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'L14 3PE', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Liverpool Heart and Chest Hospital NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'BHF Centre of Cardiovascular Science, University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'P.J. Devereaux, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'McMaster University'}, {'name': 'Andre Lamy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Richard Whitlock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Diagnostics Division', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Cardiac Surgeon', 'investigatorFullName': 'Andre Lamy', 'investigatorAffiliation': 'Population Health Research Institute'}}}}