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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01842568




Registration number
NCT01842568
Ethics application status
Date submitted
17/04/2013
Date registered
29/04/2013
Date last updated
28/06/2024

Titles & IDs
Public title
Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
Scientific title
Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
Secondary ID [1] 0 0
VISION Cardiac Surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular Death 0 0
Myocardial Infarction 0 0
Stroke 0 0
Cardiac Surgery 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality at 30-days after surgery
Timepoint [1] 0 0
30 days after surgery
Primary outcome [2] 0 0
Myocardial injuries that were not identified clinically during the first 5 days after surgery
Timepoint [2] 0 0
5 days after surgery
Primary outcome [3] 0 0
Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
Timepoint [3] 0 0
30 days after surgery
Primary outcome [4] 0 0
Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
Timepoint [4] 0 0
1 year after surgery
Secondary outcome [1] 0 0
Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device
Timepoint [1] 0 0
30 days after surgery
Secondary outcome [2] 0 0
Total mortality
Timepoint [2] 0 0
30 days after surgery
Secondary outcome [3] 0 0
Total mortality
Timepoint [3] 0 0
1 year after surgery
Secondary outcome [4] 0 0
Vascular mortality
Timepoint [4] 0 0
30 days after surgery
Secondary outcome [5] 0 0
Vascular mortality
Timepoint [5] 0 0
1 year after surgery
Secondary outcome [6] 0 0
Myocardial infarction
Timepoint [6] 0 0
30 days after surgery
Secondary outcome [7] 0 0
Myocardial infarction
Timepoint [7] 0 0
1 year after surgery
Secondary outcome [8] 0 0
Non-fatal cardiac arrest
Timepoint [8] 0 0
30 days after surgery
Secondary outcome [9] 0 0
Non-fatal cardiac arrest
Timepoint [9] 0 0
1 year after surgery
Secondary outcome [10] 0 0
Stroke
Timepoint [10] 0 0
30 days after surgery
Secondary outcome [11] 0 0
Stroke
Timepoint [11] 0 0
1 year after surgery
Secondary outcome [12] 0 0
Implantation of mechanical assist device
Timepoint [12] 0 0
30 days after surgery
Secondary outcome [13] 0 0
Implantation of mechanical assist device
Timepoint [13] 0 0
1 year after surgery
Secondary outcome [14] 0 0
Cardiac transplant
Timepoint [14] 0 0
30 days after surgery
Secondary outcome [15] 0 0
Cardiac transplant
Timepoint [15] 0 0
1 year after surgery
Secondary outcome [16] 0 0
Repeat cardiac revascularization procedures
Timepoint [16] 0 0
30 days after surgery
Secondary outcome [17] 0 0
Repeat cardiac revascularization procedures
Timepoint [17] 0 0
1 year after surgery
Secondary outcome [18] 0 0
Congestive heart failure
Timepoint [18] 0 0
30 days after surgery
Secondary outcome [19] 0 0
Congestive heart failure
Timepoint [19] 0 0
1 year after surgery
Secondary outcome [20] 0 0
New atrial fibrillation
Timepoint [20] 0 0
30 days after surgery
Secondary outcome [21] 0 0
New atrial fibrillation
Timepoint [21] 0 0
1 year after surgery
Secondary outcome [22] 0 0
Pulmonary embolus
Timepoint [22] 0 0
30 days after surgery
Secondary outcome [23] 0 0
Pulmonary embolus
Timepoint [23] 0 0
1 year after surgery
Secondary outcome [24] 0 0
Deep venous thrombosis
Timepoint [24] 0 0
30 days after surgery
Secondary outcome [25] 0 0
Deep venous thrombosis
Timepoint [25] 0 0
1 year after surgery
Secondary outcome [26] 0 0
Major bleeding
Timepoint [26] 0 0
30 days after surgery
Secondary outcome [27] 0 0
Major bleeding
Timepoint [27] 0 0
1 year after surgery
Secondary outcome [28] 0 0
New dialysis
Timepoint [28] 0 0
30 days after surgery
Secondary outcome [29] 0 0
New dialysis
Timepoint [29] 0 0
1 year after surgery
Secondary outcome [30] 0 0
Infection
Timepoint [30] 0 0
30 days after surgery
Secondary outcome [31] 0 0
Infection
Timepoint [31] 0 0
1 year after surgery
Secondary outcome [32] 0 0
Re-hospitalization for a vascular reason
Timepoint [32] 0 0
30 days after surgery
Secondary outcome [33] 0 0
Re-hospitalization for a vascular reason
Timepoint [33] 0 0
1 year after surgery
Secondary outcome [34] 0 0
Chronic incisional pain
Timepoint [34] 0 0
30 days after surgery
Secondary outcome [35] 0 0
Chronic incisional pain
Timepoint [35] 0 0
1 year after surgery
Secondary outcome [36] 0 0
Frailty
Timepoint [36] 0 0
30 days after surgery
Secondary outcome [37] 0 0
Frailty
Timepoint [37] 0 0
1 year after surgery

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
15989
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Brazil
State/province [2] 0 0
Rio Grande Do Sul
Country [3] 0 0
Brazil
State/province [3] 0 0
RS
Country [4] 0 0
Brazil
State/province [4] 0 0
São Paulo
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
China
State/province [6] 0 0
XinJiang
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Hong Kong, SAR
Country [8] 0 0
Italy
State/province [8] 0 0
Bari
Country [9] 0 0
Italy
State/province [9] 0 0
Milan
Country [10] 0 0
Malaysia
State/province [10] 0 0
Kuala Lumpur
Country [11] 0 0
Poland
State/province [11] 0 0
Gdansk
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Kemerovo
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Novosibirsk
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Essex
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Lancashire
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Merseyside
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Edinburgh
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Abbott Diagnostics Division
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01842568
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
P.J. Devereaux, MD, PhD
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01842568