Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

NCT01842568 | Completed

• 1 other identifier: VISION Cardiac Surgery
• Study Type: observational
• Target: 15,989
• Locations: 12 countries
• Sites: 24

Brief Summary

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.

Conditions

Vascular Death; Myocardial Infarction; Stroke; Cardiac Surgery

Keywords

Cardiac surgery; Troponin; Vascular events; Myocardial injury; Observational cohort study; Public health

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (37)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone cardiac surgery who are at least 18 years of age.

You may qualify if:

• Age ≥ 18 years.
• Patients who have undergone cardiac surgery. This includes coronary artery bypass grafting and all open heart procedures such as valvular repairs/replacement.

You may not qualify if:

• Previously enrolled in the VISION Cardiac Surgery Study.
• Patients who have undergone an isolated pericardial window, pericardiectomy, permanent pacemaker or defibrillator implantation.

Sponsors & Collaborators

• Population Health Research Institute: lead
• Abbott Diagnostics Division: collaborator

Study Sites (24)

Ronald Reagan Medical Centre, UCLA

Los Angeles, California, 90095, United States

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Location

Hospital de Clínicas de Porto Alegre - HCPA

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Instituto de Cardiologia do RS

Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

Location

INCOR

São Paulo, 05403-000, Brazil

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

First Teaching Hospital

Xinjiang, China

Location

Prince of Wales Hospital

Shatin, Hong Kong, SAR, NT, Hong Kong

Location

Santa Maria Hospital, GVM Care and Research

Bari, 70124, Italy

Location

University of Bari "Aldo Moro"

Bari, Italy

Location

San Raffaele Scientific Institute

Milan, 20132, Italy

Location

Institut Jantung Negara Sdn. Bhd.

Kuala Lumpur, 50400, Malaysia

Location

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Department of Cardiovascular Surgery, Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Federal State Budgetary Institution "Research Institute for Complex Issues of Cardiovascular Diseases"

Kemerovo, 650002, Russia

Location

Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Essex Cardiothoracic Centre, Basildon and Thurrock University NHS Trust

Basildon, Essex, SS16 5NL, United Kingdom

Location

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, Lancashire, FY3 8NR, United Kingdom

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

BHF Centre of Cardiovascular Science, University of Edinburgh

Edinburgh, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (4)

• 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: 35235725 DERIVED

• 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: 34330417 DERIVED

• 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: 30826789 DERIVED

• 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.

  PMID: 30686303 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Stroke

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• P.J. Devereaux, MD, PhD

  McMaster University

  STUDY CHAIR

• Andre Lamy, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Richard Whitlock, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Cardiac Surgeon

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 29, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1); AU (1); RU (2); HK (1); PL (1); BR (3); GB (5); ES (1); IT (3); CA (3); MY (2); CN (1)