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Sponsor study identifier
observational
15,989
12 countries
24
Study Start
May 2013
Actual (reported)Primary Completion
May 2022
Actual (reported)Study Completion
July 2025
Actual (reported)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. This 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 17, 2013
Actual (reported)April 29, 2013
Actual (reported)May 2013
Actual (reported)May 2022
Actual (reported)July 2025
Actual (reported)All-cause mortality at 30-days after surgery
All-cause mortality at 30-days after surgery
30 days after surgery
Myocardial injuries that were not identified clinically during the first 5 days after surgery
Myocardial injuries that were not identified clinically during the first 5 days after surgery
5 days after surgery
Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
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)
30 days after surgery
Patients who have undergone cardiac surgery who are at least 18 years of age.
Ronald Reagan Medical Centre, UCLA
Los Angeles, California, 90095, United States
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Hospital de Clínicas de Porto Alegre - HCPA
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Instituto de Cardiologia do RS
Porto Alegre, Rio Grande do Sul, 90620-001, Brazil
INCOR
São Paulo, 05403-000, Brazil
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2, Canada
Kingston General Hospital
Kingston, Ontario, Canada
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.
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.
P.J. Devereaux, MD, PhD
McMaster University
Andre Lamy, MD
McMaster University
Richard Whitlock, MD
McMaster University
15,989 participants (actual enrollment reported by the registry).
First Submitted
April 17, 2013
First Posted
April 29, 2013
Study Start
May 2013
Actual (reported)Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
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)
1 year after surgery
Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device
30 days after surgery
Total mortality
30 days after surgery
Total mortality
1 year after surgery
Vascular mortality
30 days after surgery
Vascular mortality
1 year after surgery
Contact the study team to confirm eligibility.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
First Teaching Hospital
Xinjiang, China
Prince of Wales Hospital
Shatin, Hong Kong, SAR, NT, Hong Kong
Santa Maria Hospital, GVM Care and Research
Bari, 70124, Italy
University of Bari "Aldo Moro"
Bari, Italy
San Raffaele Scientific Institute
Milan, 20132, Italy
Institut Jantung Negara Sdn. Bhd.
Kuala Lumpur, 50400, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Department of Cardiovascular Surgery, Medical University of Gdansk
Gdansk, 80-211, Poland
Federal State Budgetary Institution "Research Institute for Complex Issues of Cardiovascular Diseases"
Kemerovo, 650002, Russia
Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Essex Cardiothoracic Centre, Basildon and Thurrock University NHS Trust
Basildon, Essex, SS16 5NL, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, Lancashire, FY3 8NR, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, Merseyside, L14 3PE, United Kingdom
BHF Centre of Cardiovascular Science, University of Edinburgh
Edinburgh, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
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.
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.
Primary Completion
May 2022
Actual (reported)Study Completion
July 2025
Actual (reported)Last Updated
July 31, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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