AzTrials
AzTrials

Vascular DeathVISIONNCT00512109

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

An observational study of Vascular Death and Myocardial Infarction, run by McMaster University at 8 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 45 years and older
How many people
40,060 participants
Where
8 sitesin 7 countries
Study dates
Aug 2007to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 7 countries.

8 sites in 7 countries

Canada2 sites

  • Health Science Centre, McMaster University

    Hamilton, Ontario, L8N 3Z5

  • Saint Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

Brazil1 site

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

    São Paulo, São Paulo, 04005-000

Other trials in Brazil

China1 site

  • Prince of Wales Hospital

    Hong Kong

Other trials in China

Colombia1 site

  • Universidad Autónoma de Bucaramanga

    Bucaramanga, Santander Department

Other trials in Colombia

India1 site

  • St. John's Medical College

    Bangalore

Other trials in India

Malaysia1 site

  • Hospital: University Malaya

    Kuala Lumpur, 50603

Other trials in Malaysia

Spain1 site

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

    Barcelona, 08041

Other trials in Spain

About this study

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

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.

Read the detailed description

The increase in elderly patients undergoing surgery, the change in the invasiveness of some surgical interventions, limitations in the methodology and generalizability of previous research, and the VISION Pilot Study results highlight uncertainty about the current incidence of major vascular events and the optimal clinical risk estimation model to predict these events in patients undergoing noncardiac surgery. There is promising but inconclusive preliminary evidence that troponin measurements after surgery may allow physicians to avoid missing perioperative myocardial infarctions and may predict mortality and major vascular events in the first year following surgery. These considerations provide the impetus for the large, adequately powered, multicentre, international, prospective cohort study.

We will determine the incidence of major vascular events, the optimal clinical model to predict major perioperative vascular events, and the extent to which troponin measurements post surgery can identify myocardial infarctions that are likely to go unrecognized and predict vascular death at 1 year. We call this study the Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study.

The VISION Study is a prospective cohort study of 40,000 patients who are > 45 years of age, undergoing noncardiac surgery requiring overnight hospital admission, and receiving a general or regional anesthetic. Hospitals (including both university and non-university hospitals) in several countries around the world will recruit patients, over a 2 year period. Study personnel will evaluate patients prior to surgery, follow patients throughout their hospitalization, and contact patients at 30 days and 1 year after surgery. All patients will have troponin T measured post surgery and on the first, second, and third days after surgery. Outcome adjudicators will adjudicate all major vascular events without knowledge of a patient's vascular risk factors.

We will also determine if there are associations between any preoperative or postoperative medications and major perioperative vascular events. We will also determine if there are associations between any medications started after a major perioperative vascular event and vascular mortality 1 year after surgery. We will evaluate the 1 year risk of stroke in patients who do and do not develop atrial fibrillation after surgery and if there is an association with antiplatelet or warfarin therapy. We will measure N-terminal prohormone brain natriuretic peptide (NT-proBNP) in 8,000 - 10,000 patients prior to surgery and determine if NT-proBNP is an independent predictor of major perioperative vascular events. We will determine the incidence of perioperative new acute renal failure requiring dialysis and pneumonia and develop models to predict these events.

Keywords
vascular risk, perioperative, vascular events, cohort study, surgery
Medical subject headings
Myocardial Infarction, Heart Arrest, Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 30 days post surgery.

Secondary outcomes (3)

  1. 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.

    Measured: 30 days after surgery.

  2. 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

    Measured: 30 days after surgery.

  3. 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)

    Measured: 1 year after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40,060 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00512109
Sponsor's protocol ID
VISIONAUG2/2007
Acronym
VISION
Status last verified
Mar 2016
First submitted
3 Aug 2007
Last updated
24 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40496371

  • 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.

    PubMed 40252258

  • 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.

    PubMed 39753401

  • 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.

    PubMed 38911647

  • 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.

    PubMed 36762424

  • 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.

    PubMed 35987704

  • 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.

    PubMed 35417425

  • 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.

    PubMed 33288505

  • 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.

    PubMed 32768179

  • 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.

    PubMed 32718723

  • 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.

    PubMed 31358597

  • 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.

    PubMed 28943515

  • 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.

    PubMed 28486646

  • 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.

    PubMed 28069624

  • 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.

    PubMed 27440628

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Death and Myocardial Infarction, run by McMaster University at 8 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada, Brazil, China, Colombia, India and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 30 days post surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00512109, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in