Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION)

NCT00512109 | Completed

• 1 other identifier: VISIONAUG2/2007
• Study Type: observational
• Target: 40,060
• Locations: 7 countries
• Sites: 8

Brief Summary

The investigators' study has 4 primary objectives. Among patients undergoing noncardiac surgery the investigators will determine: (1) the incidence of major perioperative vascular events; (2) the optimal clinical model to predict major perioperative vascular events; (3) the proportion of patients with perioperative myocardial infarctions that may go undetected without perioperative troponin monitoring; and (4) the relationship between postoperative troponin measurements and the 1 year risk of vascular death.

Conditions

Vascular Death; Myocardial Infarction; Cardiac Arrest; Stroke

Keywords

vascular risk; perioperative; vascular events; cohort study; surgery

Outcome Measures

Primary Outcomes (1)

• For our first objective (i.e., the incidence of major perioperative vascular events) our primary outcome is major vascular events (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke)

  30 days post surgery.

Secondary Outcomes (3)

• For our second objective (i.e., the optimal clinical model to predict major perioperative vascular events) our primary and only outcome is major vascular events.

  30 days after surgery.

• For our third objective (i.e., proportion of patients with perioperative myocardial infarctions that may go undetected without perioperative troponin monitoring) our outcome is myocardial infarction that probably or possibly would have gone undetected

  30 days after surgery.

• For our fourth objective (i.e., the relationship between postoperative troponin measurements and the 1 year risk of vascular death) our outcomes are vascular death, and major vascular events (i.e., vascular death, MI, cardiac arrest, stroke)

  1 year after surgery.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who undergo noncardiac surgery who are at least 45 years of age and receive a general or regional anesthetic from University and Non-University Hospitals.

You may qualify if:

• All patients who undergo noncardiac surgery are eligible if they are \> 45 years of age and receive a general or regional anesthetic (i.e., plexus block, spinal, or epidural).

You may not qualify if:

• We will exclude patients undergoing noncardiac surgery who do not require at least an overnight hospital admission after surgery or who only receive infiltrative (i.e., local) or topical anesthesia.
• We will also exclude patients previously enrolled in the VISION Study and patients who do not consent to participate.

Sponsors & Collaborators

• McMaster University: lead
• Roche Diagnostic Ltd.: collaborator
• Heart and Stroke Foundation of Ontario: collaborator
• Population Health Research Institute: collaborator
• Ministry of Research, Innovation and Science, Ontario: collaborator
• Hamilton Health Sciences Corporation: collaborator
• CLARITY Group: collaborator

Study Sites (8)

Instituto de Ensino e Pesquisa do Hospital do Coração (IEP-HCor)

São Paulo, São Paulo, 04005-000, Brazil

Location

Health Science Centre, McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Saint Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Prince of Wales Hospital

Hong Kong, China

Location

Universidad Autónoma de Bucaramanga

Bucaramanga, Santander Department, Colombia

Location

St. John's Medical College

Bangalore, India

Location

Hospital: University Malaya

Kuala Lumpur, 50603, Malaysia

Location

Centro Cochrane Iberoamericano. Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Related Publications (17)

• Yang SS, Malaga G, Lazo-Porras M, Busta-Flores P, Del Carmen Rotta-Rotta A, Roshanov PS, Sessler DI, Bessissow A, Schricker T, Tagalakis V, Heels-Ansdell D, Pettit S, Devereaux PJ. Derivation and internal-external validation of clinical prediction model for postoperative clinically important hypotension in patients undergoing noncardiac surgery: an international prospective cohort study. BJA Open. 2025 May 22;14:100410. doi: 10.1016/j.bjao.2025.100410. eCollection 2025 Jun.

  PMID: 40496371 DERIVED

• El-Gabalawy R, Sommer JL, Sareen J, Mackenzie CS, Devereaux PJ, Penner K, Srinathan S. Preoperative psychological distress is associated with mortality within 1 year of non-cardiac surgery. Gen Hosp Psychiatry. 2025 Jul-Aug;95:25-31. doi: 10.1016/j.genhosppsych.2025.04.002. Epub 2025 Apr 11.

  PMID: 40252258 DERIVED

• Roshanov PS, Walsh MW, Garg AX, Cuerden M, Lam NN, Hildebrand AM, Lee VW, Mrkobrada M, Leslie K, Chan MTV, Borges FK, Wang CY, Xavier D, Sessler DI, Szczeklik W, Meyhoff CS, Srinathan SK, Sigamani A, Villar JC, Chow CK, Polanczyk CA, Patel A, Harrison TG, Fielding-Singh V, Cata JP, Parlow J, de Nadal M, Devereaux PJ. Preoperative estimated glomerular filtration rate to predict cardiac events in major noncardiac surgery: a secondary analysis of two large international studies. Br J Anaesth. 2025 Feb;134(2):297-307. doi: 10.1016/j.bja.2024.10.039. Epub 2025 Jan 2.

  PMID: 39753401 DERIVED

• McGillion MH, Borges FK, Conen D, Sessler DI, Coleman BL, Marcucci M, Ouellette C, Bird M, Whitmore C, Henry S, Ofori S, Pettit SM, Bedini DM, Gauthier LP, Lounsbury J, Carter NM, Tandon V, Patel A, Cafaro T, Simunovic MR, Harlock JA, Heels-Ansdell D, Elias F, Rapanos T, Forbes S, Peter E, Watt-Watson J, Metcalfe K, Carroll SL, Devereaux PJ. Risk Factors for Hospital Readmission Following Noncardiac Surgery: International Cohort Study. Ann Surg Open. 2024 Apr 9;5(2):e417. doi: 10.1097/AS9.0000000000000417. eCollection 2024 Jun.

  PMID: 38911647 DERIVED

• Borges FK, Duceppe E, Heels-Ansdell D, Patel A, Sessler DI, Tandon V, Chan M, Pearse R, Srinathan S, Garg AX, Sapsford RJ, Ofori SN, Marcucci M, Kavsak PA, Pettit S, Spence J, Belley-Cote E, McGillion M, Whitlock R, Lamy A, Conen D, Thomas S, Mueller C, Jaffe AS, Devereaux PJ. High-sensitivity Troponin I Predicts Major Cardiovascular Events after Non-Cardiac Surgery: A Vascular Events in Non-Cardiac Surgery Patients Cohort Evaluation (VISION) Substudy. Clin Chem. 2023 Apr 28;69(5):492-499. doi: 10.1093/clinchem/hvad005.

  PMID: 36762424 DERIVED

• Ofori SN, Marcucci M, Mbuagbaw L, Conen D, Borges FK, Chow CK, Sessler DI, Chan MTV, Hillis GS, Pettit S, Heels-Ansdell D, Devereaux PJ; Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study Investigators. Determinants of tobacco smoking abstinence one year after major noncardiac surgery: a secondary analysis of the VISION study. Br J Anaesth. 2022 Oct;129(4):497-505. doi: 10.1016/j.bja.2022.07.010. Epub 2022 Aug 18.

  PMID: 35987704 DERIVED

• Pedersen SS, Holse C, Mathar CE, Chan MTV, Sessler DI, Liu Y, Zhang L, Kurz A, Jacka M, Torborg A, Biyase T, Montes FR, Wang CY, Pettit S, Devereaux PJ, Meyhoff CS. Intraoperative Inspiratory Oxygen Fraction and Myocardial Injury After Noncardiac Surgery: Results From an International Observational Study in Relation to Recent Controlled Trials. Anesth Analg. 2022 Nov 1;135(5):1021-1030. doi: 10.1213/ANE.0000000000006042. Epub 2022 Apr 13.

  PMID: 35417425 DERIVED

• Szczeklik W, LeManach Y, Fronczek J, Polok K, Conen D, McAlister FA, Srinathan S, Alonso-Coello P, Biccard B, Duceppe E, Heels-Ansdell D, Gorka J, Pettit S, Roshanov PS, Devereaux PJ. Preoperative levels of natriuretic peptides and the incidence of postoperative atrial fibrillation after noncardiac surgery: a prospective cohort study. CMAJ. 2020 Dec 7;192(49):E1715-E1722. doi: 10.1503/cmaj.200840.

  PMID: 33288505 DERIVED

• Roshanov PS, Eikelboom JW, Sessler DI, Kearon C, Guyatt GH, Crowther M, Tandon V, Borges FK, Lamy A, Whitlock R, Biccard BM, Szczeklik W, Panju M, Spence J, Garg AX, McGillion M, VanHelder T, Kavsak PA, de Beer J, Winemaker M, Le Manach Y, Sheth T, Pinthus JH, Siegal D, Thabane L, Simunovic MRI, Mizera R, Ribas S, Devereaux PJ. Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS): an international prospective cohort study establishing diagnostic criteria and prognostic importance. Br J Anaesth. 2021 Jan;126(1):163-171. doi: 10.1016/j.bja.2020.06.051. Epub 2020 Aug 5.

  PMID: 32768179 DERIVED

• Roshanov PS, Guyatt GH, Tandon V, Borges FK, Lamy A, Whitlock R, Biccard BM, Szczeklik W, Panju M, Spence J, Garg AX, McGillion M, Eikelboom JW, Sessler DI, Kearon C, Crowther M, VanHelder T, Kavsak PA, de Beer J, Winemaker M, Le Manach Y, Sheth T, Pinthus JH, Siegal D, Thabane L, Simunovic MRI, Mizera R, Ribas S, Devereaux PJ. Preoperative prediction of Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS): an international prospective cohort study. Br J Anaesth. 2021 Jan;126(1):172-180. doi: 10.1016/j.bja.2020.02.028. Epub 2020 Jul 24.

  PMID: 32718723 DERIVED

• Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Spence J, LeManach Y, Chan MTV, Wang CY, Sigamani A, Xavier D, Pearse R, Alonso-Coello P, Garutti I, Srinathan SK, Duceppe E, Walsh M, Borges FK, Malaga G, Abraham V, Faruqui A, Berwanger O, Biccard BM, Villar JC, Sessler DI, Kurz A, Chow CK, Polanczyk CA, Szczeklik W, Ackland G, X GA, Jacka M, Guyatt GH, Sapsford RJ, Williams C, Cortes OL, Coriat P, Patel A, Tiboni M, Belley-Cote EP, Yang S, Heels-Ansdell D, McGillion M, Parlow S, Patel M, Pettit S, Yusuf S, Devereaux PJ. Association between complications and death within 30 days after noncardiac surgery. CMAJ. 2019 Jul 29;191(30):E830-E837. doi: 10.1503/cmaj.190221.

  PMID: 31358597 DERIVED

• Roshanov PS, Eikelboom JW, Crowther M, Tandon V, Borges FK, Kearon C, Lamy A, Whitlock R, Biccard BM, Szczeklik W, Guyatt GH, Panju M, Spence J, Garg AX, McGillion M, VanHelder T, Kavsak PA, de Beer J, Winemaker M, Sessler DI, Le Manach Y, Sheth T, Pinthus JH, Thabane L, Simunovic MRI, Mizera R, Ribas S, Devereaux PJ; Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Investigators. Bleeding impacting mortality after noncardiac surgery: a protocol to establish diagnostic criteria, estimate prognostic importance, and develop and validate a prediction guide in an international prospective cohort study. CMAJ Open. 2017 Aug 4;5(3):E594-E603. doi: 10.9778/cmajo.20160106.

  PMID: 28943515 DERIVED

• Gorka J, Polok K, Iwaniec T, Gorka K, Wludarczyk A, Fronczek J, Devereaux PJ, Eikelboom JW, Musial J, Szczeklik W. Altered preoperative coagulation and fibrinolysis are associated with myocardial injury after non-cardiac surgery. Br J Anaesth. 2017 May 1;118(5):713-719. doi: 10.1093/bja/aex081.

  PMID: 28486646 DERIVED

• Roshanov PS, Walsh M, Devereaux PJ, MacNeil SD, Lam NN, Hildebrand AM, Acedillo RR, Mrkobrada M, Chow CK, Lee VW, Thabane L, Garg AX. External validation of the Revised Cardiac Risk Index and update of its renal variable to predict 30-day risk of major cardiac complications after non-cardiac surgery: rationale and plan for analyses of the VISION study. BMJ Open. 2017 Jan 9;7(1):e013510. doi: 10.1136/bmjopen-2016-013510.

  PMID: 28069624 DERIVED

• Abbott TE, Ackland GL, Archbold RA, Wragg A, Kam E, Ahmad T, Khan AW, Niebrzegowska E, Rodseth RN, Devereaux PJ, Pearse RM. Preoperative heart rate and myocardial injury after non-cardiac surgery: results of a predefined secondary analysis of the VISION study. Br J Anaesth. 2016 Aug;117(2):172-81. doi: 10.1093/bja/aew182.

  PMID: 27440628 DERIVED

• Khanna AK, Sessler DI, Sun Z, Naylor AJ, You J, Hesler BD, Kurz A, Devereaux PJ, Saager L. Using the STOP-BANG questionnaire to predict hypoxaemia in patients recovering from noncardiac surgery: a prospective cohort analysis. Br J Anaesth. 2016 May;116(5):632-40. doi: 10.1093/bja/aew029.

  PMID: 27106966 DERIVED

• Berwanger O, Le Manach Y, Suzumura EA, Biccard B, Srinathan SK, Szczeklik W, Santo JA, Santucci E, Cavalcanti AB, Archbold RA, Devereaux PJ; VISION Investigators. Association between pre-operative statin use and major cardiovascular complications among patients undergoing non-cardiac surgery: the VISION study. Eur Heart J. 2016 Jan 7;37(2):177-85. doi: 10.1093/eurheartj/ehv456. Epub 2015 Sep 1.

  PMID: 26330424 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Heart Arrest; 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

• Philip J Devereaux, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 7, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 24, 2018

Record last verified: 2016-03

Locations

CO (1); ES (1); MY (1); IN (1); BR (1); CA (2); CN (1)