Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
Query!
Secondary ID [1]
0
0
VISION Cardiac Surgery
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Vascular Death
0
0
Query!
Myocardial Infarction
0
0
Query!
Stroke
0
0
Query!
Cardiac Surgery
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
All-cause mortality at 30-days after surgery
Query!
Assessment method [1]
0
0
All-cause mortality at 30-days after surgery
Query!
Timepoint [1]
0
0
30 days after surgery
Query!
Primary outcome [2]
0
0
Myocardial injuries that were not identified clinically during the first 5 days after surgery
Query!
Assessment method [2]
0
0
Myocardial injuries that were not identified clinically during the first 5 days after surgery
Query!
Timepoint [2]
0
0
5 days after surgery
Query!
Primary outcome [3]
0
0
Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
Query!
Assessment method [3]
0
0
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)
Query!
Timepoint [3]
0
0
30 days after surgery
Query!
Primary outcome [4]
0
0
Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
Query!
Assessment method [4]
0
0
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)
Query!
Timepoint [4]
0
0
1 year after surgery
Query!
Secondary outcome [1]
0
0
Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device
Query!
Assessment method [1]
0
0
Major vascular complications at 30-days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device)
Query!
Timepoint [1]
0
0
30 days after surgery
Query!
Secondary outcome [2]
0
0
Total mortality
Query!
Assessment method [2]
0
0
Total mortality
Query!
Timepoint [2]
0
0
30 days after surgery
Query!
Secondary outcome [3]
0
0
Total mortality
Query!
Assessment method [3]
0
0
Total mortality
Query!
Timepoint [3]
0
0
1 year after surgery
Query!
Secondary outcome [4]
0
0
Vascular mortality
Query!
Assessment method [4]
0
0
death due to vascular cause
Query!
Timepoint [4]
0
0
30 days after surgery
Query!
Secondary outcome [5]
0
0
Vascular mortality
Query!
Assessment method [5]
0
0
death due to vascular cause
Query!
Timepoint [5]
0
0
1 year after surgery
Query!
Secondary outcome [6]
0
0
Myocardial infarction
Query!
Assessment method [6]
0
0
Myocardial infarction
Query!
Timepoint [6]
0
0
30 days after surgery
Query!
Secondary outcome [7]
0
0
Myocardial infarction
Query!
Assessment method [7]
0
0
Myocardial infarction
Query!
Timepoint [7]
0
0
1 year after surgery
Query!
Secondary outcome [8]
0
0
Non-fatal cardiac arrest
Query!
Assessment method [8]
0
0
Non-fatal cardiac arrest
Query!
Timepoint [8]
0
0
30 days after surgery
Query!
Secondary outcome [9]
0
0
Non-fatal cardiac arrest
Query!
Assessment method [9]
0
0
Non-fatal cardiac arrest
Query!
Timepoint [9]
0
0
1 year after surgery
Query!
Secondary outcome [10]
0
0
Stroke
Query!
Assessment method [10]
0
0
Stroke
Query!
Timepoint [10]
0
0
30 days after surgery
Query!
Secondary outcome [11]
0
0
Stroke
Query!
Assessment method [11]
0
0
Stroke
Query!
Timepoint [11]
0
0
1 year after surgery
Query!
Secondary outcome [12]
0
0
Implantation of mechanical assist device
Query!
Assessment method [12]
0
0
Implantation of mechanical assist device
Query!
Timepoint [12]
0
0
30 days after surgery
Query!
Secondary outcome [13]
0
0
Implantation of mechanical assist device
Query!
Assessment method [13]
0
0
Implantation of mechanical assist device
Query!
Timepoint [13]
0
0
1 year after surgery
Query!
Secondary outcome [14]
0
0
Cardiac transplant
Query!
Assessment method [14]
0
0
Cardiac transplant
Query!
Timepoint [14]
0
0
30 days after surgery
Query!
Secondary outcome [15]
0
0
Cardiac transplant
Query!
Assessment method [15]
0
0
Cardiac transplant
Query!
Timepoint [15]
0
0
1 year after surgery
Query!
Secondary outcome [16]
0
0
Repeat cardiac revascularization procedures
Query!
Assessment method [16]
0
0
Repeat cardiac revascularization procedures
Query!
Timepoint [16]
0
0
30 days after surgery
Query!
Secondary outcome [17]
0
0
Repeat cardiac revascularization procedures
Query!
Assessment method [17]
0
0
Repeat cardiac revascularization procedures
Query!
Timepoint [17]
0
0
1 year after surgery
Query!
Secondary outcome [18]
0
0
Congestive heart failure
Query!
Assessment method [18]
0
0
Congestive heart failure
Query!
Timepoint [18]
0
0
30 days after surgery
Query!
Secondary outcome [19]
0
0
Congestive heart failure
Query!
Assessment method [19]
0
0
Congestive heart failure
Query!
Timepoint [19]
0
0
1 year after surgery
Query!
Secondary outcome [20]
0
0
New atrial fibrillation
Query!
Assessment method [20]
0
0
New clinically important atrial fibrillation
Query!
Timepoint [20]
0
0
30 days after surgery
Query!
Secondary outcome [21]
0
0
New atrial fibrillation
Query!
Assessment method [21]
0
0
New clinically important atrial fibrillation
Query!
Timepoint [21]
0
0
1 year after surgery
Query!
Secondary outcome [22]
0
0
Pulmonary embolus
Query!
Assessment method [22]
0
0
Pulmonary embolus
Query!
Timepoint [22]
0
0
30 days after surgery
Query!
Secondary outcome [23]
0
0
Pulmonary embolus
Query!
Assessment method [23]
0
0
Pulmonary embolus
Query!
Timepoint [23]
0
0
1 year after surgery
Query!
Secondary outcome [24]
0
0
Deep venous thrombosis
Query!
Assessment method [24]
0
0
Deep venous thrombosis
Query!
Timepoint [24]
0
0
30 days after surgery
Query!
Secondary outcome [25]
0
0
Deep venous thrombosis
Query!
Assessment method [25]
0
0
Deep venous thrombosis
Query!
Timepoint [25]
0
0
1 year after surgery
Query!
Secondary outcome [26]
0
0
Major bleeding
Query!
Assessment method [26]
0
0
Major bleeding
Query!
Timepoint [26]
0
0
30 days after surgery
Query!
Secondary outcome [27]
0
0
Major bleeding
Query!
Assessment method [27]
0
0
Major bleeding
Query!
Timepoint [27]
0
0
1 year after surgery
Query!
Secondary outcome [28]
0
0
New dialysis
Query!
Assessment method [28]
0
0
New dialysis
Query!
Timepoint [28]
0
0
30 days after surgery
Query!
Secondary outcome [29]
0
0
New dialysis
Query!
Assessment method [29]
0
0
New dialysis
Query!
Timepoint [29]
0
0
1 year after surgery
Query!
Secondary outcome [30]
0
0
Infection
Query!
Assessment method [30]
0
0
Infection (including sternal, sepsis, pneumonia)
Query!
Timepoint [30]
0
0
30 days after surgery
Query!
Secondary outcome [31]
0
0
Infection
Query!
Assessment method [31]
0
0
Infection (including sternal, sepsis, pneumonia)
Query!
Timepoint [31]
0
0
1 year after surgery
Query!
Secondary outcome [32]
0
0
Re-hospitalization for a vascular reason
Query!
Assessment method [32]
0
0
Re-hospitalization for a vascular reason
Query!
Timepoint [32]
0
0
30 days after surgery
Query!
Secondary outcome [33]
0
0
Re-hospitalization for a vascular reason
Query!
Assessment method [33]
0
0
Re-hospitalization for a vascular reason
Query!
Timepoint [33]
0
0
1 year after surgery
Query!
Secondary outcome [34]
0
0
Chronic incisional pain
Query!
Assessment method [34]
0
0
Chronic incisional pain
Query!
Timepoint [34]
0
0
30 days after surgery
Query!
Secondary outcome [35]
0
0
Chronic incisional pain
Query!
Assessment method [35]
0
0
Chronic incisional pain
Query!
Timepoint [35]
0
0
1 year after surgery
Query!
Secondary outcome [36]
0
0
Frailty
Query!
Assessment method [36]
0
0
Frailty assessed by PRISMA-7 questionnaire
Query!
Timepoint [36]
0
0
30 days after surgery
Query!
Secondary outcome [37]
0
0
Frailty
Query!
Assessment method [37]
0
0
Frailty assessed by PRISMA-7 questionnaire
Query!
Timepoint [37]
0
0
1 year after surgery
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
15989
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Sydney
Query!
Recruitment postcode(s) [1]
0
0
- Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
Brazil
Query!
State/province [2]
0
0
Rio Grande Do Sul
Query!
Country [3]
0
0
Brazil
Query!
State/province [3]
0
0
RS
Query!
Country [4]
0
0
Brazil
Query!
State/province [4]
0
0
São Paulo
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Ontario
Query!
Country [6]
0
0
China
Query!
State/province [6]
0
0
XinJiang
Query!
Country [7]
0
0
Hong Kong
Query!
State/province [7]
0
0
Hong Kong, SAR
Query!
Country [8]
0
0
Italy
Query!
State/province [8]
0
0
Bari
Query!
Country [9]
0
0
Italy
Query!
State/province [9]
0
0
Milan
Query!
Country [10]
0
0
Malaysia
Query!
State/province [10]
0
0
Kuala Lumpur
Query!
Country [11]
0
0
Poland
Query!
State/province [11]
0
0
Gdansk
Query!
Country [12]
0
0
Russian Federation
Query!
State/province [12]
0
0
Kemerovo
Query!
Country [13]
0
0
Russian Federation
Query!
State/province [13]
0
0
Novosibirsk
Query!
Country [14]
0
0
Spain
Query!
State/province [14]
0
0
Barcelona
Query!
Country [15]
0
0
United Kingdom
Query!
State/province [15]
0
0
Essex
Query!
Country [16]
0
0
United Kingdom
Query!
State/province [16]
0
0
Lancashire
Query!
Country [17]
0
0
United Kingdom
Query!
State/province [17]
0
0
Merseyside
Query!
Country [18]
0
0
United Kingdom
Query!
State/province [18]
0
0
Edinburgh
Query!
Country [19]
0
0
United Kingdom
Query!
State/province [19]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Population Health Research Institute
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Abbott Diagnostics Division
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01842568
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
P.J. Devereaux, MD, PhD
Query!
Address
0
0
McMaster University
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01842568
Download to PDF