Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Stroke; Cardiac Surgery; Vascular Death

• Study Type: Observational
• Enrollment (Actual): 15989

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Royal Prince Alfred Hospital
• Brazil
  • São Paulo, Brazil, 05403-000
    • InCor
  • RS
    • Porto Alegre, RS, Brazil, 90620-001
      • Instituto de Cardiologia do RS
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre - HCPA
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences
    • Kingston, Ontario, Canada
      • Kingston General Hospital
    • Toronto, Ontario, Canada
      • SunnyBrook Health Sciences Centre
• China
  • XinJiang, China
    • First Teaching Hospital
• Hong Kong
  • Hong Kong, SAR
    • Shatin, Hong Kong, SAR, Hong Kong, NT
      • Prince of Wales Hospital
• Italy
  • Bari, Italy, 70124
    • Santa Maria Hospital, GVM Care and Research
  • Bari, Italy
    • University of Bari "Aldo Moro"
  • Milan, Italy, 20132
    • San Raffaele Scientific Institute
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University of Malaya Medical Centre
  • Kuala Lumpur, Malaysia, 50400
    • Institut Jantung Negara Sdn. Bhd.
• Poland
  • Gdańsk, Poland, 80-211
    • Department of Cardiovascular Surgery, Medical University of Gdansk
• Russian Federation
  • Kemerovo, Russian Federation, 650002
    • Federal State Budgetary Institution "Research Institute for Complex Issues of Cardiovascular Diseases"
  • Novosibirsk, Russian Federation, 630055
    • Research Institute of Circulation Pathology
• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
• United Kingdom
  • Edinburgh, United Kingdom
    • BHF Centre of Cardiovascular Science, University of Edinburgh
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • Essex Cardiothoracic Centre, Basildon and Thurrock University NHS Trust
  • Lancashire
    • Blackpool, Lancashire, United Kingdom, FY3 8NR
      • Blackpool Teaching Hospitals NHS Foundation Trust
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L14 3PE
      • Liverpool Heart and Chest Hospital NHS Foundation Trust
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan Medical Centre, UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days after surgery
Total mortality	Total mortality	30 days after surgery
Total mortality	Total mortality	1 year after surgery
Vascular mortality	death due to vascular cause	30 days after surgery
Vascular mortality	death due to vascular cause	1 year after surgery
Myocardial infarction	Myocardial infarction	30 days after surgery
Myocardial infarction	Myocardial infarction	1 year after surgery
Non-fatal cardiac arrest	Non-fatal cardiac arrest	30 days after surgery
Non-fatal cardiac arrest	Non-fatal cardiac arrest	1 year after surgery
Stroke	Stroke	30 days after surgery
Stroke	Stroke	1 year after surgery
Implantation of mechanical assist device	Implantation of mechanical assist device	30 days after surgery
Implantation of mechanical assist device	Implantation of mechanical assist device	1 year after surgery
Cardiac transplant	Cardiac transplant	30 days after surgery
Cardiac transplant	Cardiac transplant	1 year after surgery
Repeat cardiac revascularization procedures	Repeat cardiac revascularization procedures	30 days after surgery
Repeat cardiac revascularization procedures	Repeat cardiac revascularization procedures	1 year after surgery
Congestive heart failure	Congestive heart failure	30 days after surgery
Congestive heart failure	Congestive heart failure	1 year after surgery
New atrial fibrillation	New clinically important atrial fibrillation	30 days after surgery
New atrial fibrillation	New clinically important atrial fibrillation	1 year after surgery
Pulmonary embolus	Pulmonary embolus	30 days after surgery
Pulmonary embolus	Pulmonary embolus	1 year after surgery
Deep venous thrombosis	Deep venous thrombosis	30 days after surgery
Deep venous thrombosis	Deep venous thrombosis	1 year after surgery
Major bleeding	Major bleeding	30 days after surgery
Major bleeding	Major bleeding	1 year after surgery
New dialysis	New dialysis	30 days after surgery
New dialysis	New dialysis	1 year after surgery
Infection	Infection (including sternal, sepsis, pneumonia)	30 days after surgery
Infection	Infection (including sternal, sepsis, pneumonia)	1 year after surgery
Re-hospitalization for a vascular reason	Re-hospitalization for a vascular reason	30 days after surgery
Re-hospitalization for a vascular reason	Re-hospitalization for a vascular reason	1 year after surgery
Chronic incisional pain	Chronic incisional pain	30 days after surgery
Chronic incisional pain	Chronic incisional pain	1 year after surgery
Frailty	Frailty assessed by PRISMA-7 questionnaire	30 days after surgery
Frailty	Frailty assessed by PRISMA-7 questionnaire	1 year after surgery

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Abbott Diagnostics Division
• Investigators: Principal Investigator: Richard Whitlock, MD, McMaster University; Study Chair: P.J. Devereaux, MD, PhD, McMaster University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): May 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 24, 2013
• First Posted (Estimate): April 29, 2013

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac surgery; Myocardial injury; Troponin; Public health; Observational cohort study; Vascular events
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: VISION Cardiac Surgery