AzTrials
AzTrials

Vascular DeathNCT01842568

Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

An observational study of Vascular Death and Myocardial Infarction, run by Population Health Research Institute at 24 sites in 12 countries.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vascular Death, Myocardial Infarction, Stroke
How many people
15,989 participants
Where
24 sitesin 12 countries
Study dates
May 2013to Jul 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

24 sites in 12 countries.

24 sites in 12 countries

United Kingdom5 sites

  • Essex Cardiothoracic Centre, Basildon and Thurrock University NHS Trust

    Basildon, Essex, SS16 5NL

  • Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool, Lancashire, FY3 8NR

  • BHF Centre of Cardiovascular Science, University of Edinburgh

    Edinburgh

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, Merseyside, L14 3PE

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Brazil3 sites

  • Hospital de Clínicas de Porto Alegre - HCPA

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Instituto de Cardiologia do RS

    Porto Alegre, Rio Grande do Sul, 90620-001

  • INCOR

    São Paulo, 05403-000

Other trials in Brazil

Canada3 sites

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

  • Kingston General Hospital

    Kingston, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

Other trials in Canada

Italy3 sites

  • Santa Maria Hospital, GVM Care and Research

    Bari, 70124

  • University of Bari "Aldo Moro"

    Bari

  • San Raffaele Scientific Institute

    Milan, 20132

Other trials in Italy

Malaysia2 sites

  • Institut Jantung Negara Sdn. Bhd.

    Kuala Lumpur, 50400

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

Russia2 sites

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

    Kemerovo, 650002

  • Research Institute of Circulation Pathology

    Novosibirsk, 630055

Other trials in Russia

United States1 site

  • Ronald Reagan Medical Centre, UCLA

    Los Angeles, California, 90095

Other trials in United States

Australia1 site

  • Royal Prince Alfred Hospital

    Sydney, New South Wales

Other trials in Australia

China1 site

  • First Teaching Hospital

    Xinjiang

Other trials in China

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin, Hong Kong, SAR, NT

Other trials in Hong Kong

Poland1 site

  • Department of Cardiovascular Surgery, Medical University of Gdansk

    Gdansk, 80-211

Other trials in Poland

Spain1 site

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

Other trials in Spain

About this study

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.

Keywords
Cardiac surgery, Troponin, Vascular events, Myocardial injury, Observational cohort study, Public health
Medical subject headings
Myocardial Infarction, Stroke

What is being measured

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

  1. All-cause mortality at 30-days after surgery

    All-cause mortality at 30-days after surgery

    Measured: 30 days after surgery

  2. 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

    Measured: 5 days after surgery

  3. 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)

    Measured: 30 days after surgery

  4. 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)

    Measured: 1 year after surgery

Secondary outcomes (37)

  1. Composite of vascular death, nonfatal myocardial infarction, 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 stroke, and mechanical assist device)

    Measured: 30 days after surgery

  2. Total mortality

    Total mortality

    Measured: 30 days after surgery

  3. Total mortality

    Total mortality

    Measured: 1 year after surgery

  4. Vascular mortality

    death due to vascular cause

    Measured: 30 days after surgery

  5. Vascular mortality

    death due to vascular cause

    Measured: 1 year after surgery

  6. Myocardial infarction

    Myocardial infarction

    Measured: 30 days after surgery

  7. Myocardial infarction

    Myocardial infarction

    Measured: 1 year after surgery

  8. Non-fatal cardiac arrest

    Non-fatal cardiac arrest

    Measured: 30 days after surgery

  9. Non-fatal cardiac arrest

    Non-fatal cardiac arrest

    Measured: 1 year after surgery

  10. Stroke

    Stroke

    Measured: 30 days after surgery

  11. Stroke

    Stroke

    Measured: 1 year after surgery

  12. Implantation of mechanical assist device

    Implantation of mechanical assist device

    Measured: 30 days after surgery

  13. Implantation of mechanical assist device

    Implantation of mechanical assist device

    Measured: 1 year after surgery

  14. Cardiac transplant

    Cardiac transplant

    Measured: 30 days after surgery

  15. Cardiac transplant

    Cardiac transplant

    Measured: 1 year after surgery

  16. Repeat cardiac revascularization procedures

    Repeat cardiac revascularization procedures

    Measured: 30 days after surgery

  17. Repeat cardiac revascularization procedures

    Repeat cardiac revascularization procedures

    Measured: 1 year after surgery

  18. Congestive heart failure

    Congestive heart failure

    Measured: 30 days after surgery

  19. Congestive heart failure

    Congestive heart failure

    Measured: 1 year after surgery

  20. New atrial fibrillation

    New clinically important atrial fibrillation

    Measured: 30 days after surgery

  21. New atrial fibrillation

    New clinically important atrial fibrillation

    Measured: 1 year after surgery

  22. Pulmonary embolus

    Pulmonary embolus

    Measured: 30 days after surgery

  23. Pulmonary embolus

    Pulmonary embolus

    Measured: 1 year after surgery

  24. Deep venous thrombosis

    Deep venous thrombosis

    Measured: 30 days after surgery

  25. Deep venous thrombosis

    Deep venous thrombosis

    Measured: 1 year after surgery

  26. Major bleeding

    Major bleeding

    Measured: 30 days after surgery

  27. Major bleeding

    Major bleeding

    Measured: 1 year after surgery

  28. New dialysis

    New dialysis

    Measured: 30 days after surgery

  29. New dialysis

    New dialysis

    Measured: 1 year after surgery

  30. Infection

    Infection (including sternal, sepsis, pneumonia)

    Measured: 30 days after surgery

  31. Infection

    Infection (including sternal, sepsis, pneumonia)

    Measured: 1 year after surgery

  32. Re-hospitalization for a vascular reason

    Re-hospitalization for a vascular reason

    Measured: 30 days after surgery

  33. Re-hospitalization for a vascular reason

    Re-hospitalization for a vascular reason

    Measured: 1 year after surgery

  34. Chronic incisional pain

    Chronic incisional pain

    Measured: 30 days after surgery

  35. Chronic incisional pain

    Chronic incisional pain

    Measured: 1 year after surgery

  36. Frailty

    Frailty assessed by PRISMA-7 questionnaire

    Measured: 30 days after surgery

  37. Frailty

    Frailty assessed by PRISMA-7 questionnaire

    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 posted29 Apr 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionMay 2022
  4. Study completionJul 2025

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
15,989 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01842568
Sponsor's protocol ID
VISION Cardiac Surgery
Status last verified
Jul 2025
First submitted
17 Apr 2013
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 35235725

  • 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.

    PubMed 34330417

  • 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.

    PubMed 30826789

  • 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.

    PubMed 30686303

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Death and Myocardial Infarction, run by Population Health Research Institute at 24 sites in 12 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 2 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United Kingdom, Brazil, Canada, Italy, Malaysia and 7 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?

All-cause mortality at 30-days after surgery (time frame: 30 days after surgery). The study lists 4 primary outcomes in all. 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 NCT01842568, which also lists 4 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 31 Jul 2025.

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