Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

NCT ID: NCT01842568

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

15989 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular Death Myocardial Infarction Stroke Cardiac Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Diagnostics Division

INDUSTRY

Sponsor Role collaborator

Population Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andre Lamy

Professor and Cardiac Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

P.J. Devereaux, MD, PhD

Role: STUDY_CHAIR

McMaster University

Andre Lamy, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Richard Whitlock, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ronald Reagan Medical Centre, UCLA

Los Angeles, California, United States

Site Status

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status

Hospital de Clínicas de Porto Alegre - HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto de Cardiologia do RS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

INCOR

São Paulo, , Brazil

Site Status

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

First Teaching Hospital

Xinjiang, , China

Site Status

Prince of Wales Hospital

Shatin, Hong Kong, SAR, Hong Kong

Site Status

Santa Maria Hospital, GVM Care and Research

Bari, , Italy

Site Status

University of Bari "Aldo Moro"

Bari, , Italy

Site Status

San Raffaele Scientific Institute

Milan, , Italy

Site Status

Institut Jantung Negara Sdn. Bhd.

Kuala Lumpur, , Malaysia

Site Status

University of Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Department of Cardiovascular Surgery, Medical University of Gdansk

Gdansk, , Poland

Site Status

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

Kemerovo, , Russia

Site Status

Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Essex Cardiothoracic Centre, Basildon and Thurrock University NHS Trust

Basildon, Essex, United Kingdom

Site Status

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, Lancashire, United Kingdom

Site Status

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, Merseyside, United Kingdom

Site Status

BHF Centre of Cardiovascular Science, University of Edinburgh

Edinburgh, , United Kingdom

Site Status

New Cross Hospital

Wolverhampton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Brazil Canada China Hong Kong Italy Malaysia Poland Russia Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35235725 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34330417 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30826789 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30686303 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VISION Cardiac Surgery

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.