Clinical trial NCT01842568: Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
Official title: Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vascular Death
Myocardial Infarction
Stroke
Cardiac Surgery
Keywords: Cardiac surgery
Troponin
Vascular events
Myocardial injury
Observational cohort study
Public health
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Abbott Diagnostics Division
First posted: 2013-04-29
Enrollment: 15989
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone cardiac surgery who are at least 18 years of age.

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: All-cause mortality at 30-days after surgery
timeFrame: 30 days after surgery
measure: Myocardial injuries that were not identified clinically during the first 5 days after surgery
timeFrame: 5 days after surgery
measure: Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
timeFrame: 30 days after surgery
measure: Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device
timeFrame: 30 days after surgery
measure: Total mortality
timeFrame: 30 days after surgery
measure: Total mortality
timeFrame: 1 year after surgery
measure: Vascular mortality
timeFrame: 30 days after surgery
measure: Vascular mortality
timeFrame: 1 year after surgery
measure: Myocardial infarction
timeFrame: 30 days after surgery
measure: Myocardial infarction
timeFrame: 1 year after surgery
measure: Non-fatal cardiac arrest
timeFrame: 30 days after surgery
measure: Non-fatal cardiac arrest
timeFrame: 1 year after surgery
measure: Stroke
timeFrame: 30 days after surgery
measure: Stroke
timeFrame: 1 year after surgery
measure: Implantation of mechanical assist device
timeFrame: 30 days after surgery
measure: Implantation of mechanical assist device
timeFrame: 1 year after surgery
measure: Cardiac transplant
timeFrame: 30 days after surgery
measure: Cardiac transplant
timeFrame: 1 year after surgery
measure: Repeat cardiac revascularization procedures
timeFrame: 30 days after surgery
measure: Repeat cardiac revascularization procedures
timeFrame: 1 year after surgery
measure: Congestive heart failure
timeFrame: 30 days after surgery
measure: Congestive heart failure
timeFrame: 1 year after surgery
measure: New atrial fibrillation
timeFrame: 30 days after surgery
measure: New atrial fibrillation
timeFrame: 1 year after surgery
measure: Pulmonary embolus
timeFrame: 30 days after surgery
measure: Pulmonary embolus
timeFrame: 1 year after surgery
measure: Deep venous thrombosis
timeFrame: 30 days after surgery
measure: Deep venous thrombosis
timeFrame: 1 year after surgery
measure: Major bleeding
timeFrame: 30 days after surgery
measure: Major bleeding
timeFrame: 1 year after surgery
measure: New dialysis
timeFrame: 30 days after surgery
measure: New dialysis
timeFrame: 1 year after surgery
measure: Infection
timeFrame: 30 days after surgery
measure: Infection
timeFrame: 1 year after surgery
measure: Re-hospitalization for a vascular reason
timeFrame: 30 days after surgery
measure: Re-hospitalization for a vascular reason
timeFrame: 1 year after surgery
measure: Chronic incisional pain
timeFrame: 30 days after surgery
measure: Chronic incisional pain
timeFrame: 1 year after surgery
measure: Frailty
timeFrame: 30 days after surgery
measure: Frailty
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan Medical Centre, UCLA
state: California
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre - HCPA
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do RS
state: RS
city: São Paulo
country: Brazil
facility: INCOR
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: XinJiang
country: China
facility: First Teaching Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: Hong Kong, SAR
city: Bari
country: Italy
facility: Santa Maria Hospital, GVM Care and Research
city: Bari
country: Italy
facility: University of Bari "Aldo Moro"
city: Milan
country: Italy
facility: San Raffaele Scientific Institute
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara Sdn. Bhd.
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Gdańsk
country: Poland
facility: Department of Cardiovascular Surgery, Medical University of Gdansk
city: Kemerovo
country: Russian Federation
facility: Federal State Budgetary Institution "Research Institute for Complex Issues of Cardiovascular Diseases"
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Circulation Pathology
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Basildon
country: United Kingdom
facility: Essex Cardiothoracic Centre, Basildon and Thurrock University NHS Trust
state: Essex
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust
state: Lancashire
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
state: Merseyside
city: Edinburgh
country: United Kingdom
facility: BHF Centre of Cardiovascular Science, University of Edinburgh
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: McMaster University
name: P.J. Devereaux, MD, PhD
role: STUDY_CHAIR
affiliation: McMaster University
name: Andre Lamy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Richard Whitlock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.