Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
- Conditions
- Vascular DeathStrokeMyocardial InfarctionCardiac Surgery
- Registration Number
- NCT01842568
- Lead Sponsor
- Population Health Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15989
- 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.
- Previously enrolled in the VISION Cardiac Surgery Study.
- Patients who have undergone an isolated pericardial window, pericardiectomy, permanent pacemaker or defibrillator implantation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Myocardial injuries that were not identified clinically during the first 5 days after surgery 5 days after surgery Myocardial injuries that were not identified clinically during the first 5 days after surgery
All-cause mortality at 30-days after surgery 30 days after surgery All-cause mortality at 30-days after surgery
Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device 1 year after surgery 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)
- Secondary Outcome Measures
Name Time Method New atrial fibrillation 1 year after surgery New clinically important atrial fibrillation
Pulmonary embolus 1 year after surgery Pulmonary embolus
New dialysis 1 year after surgery New dialysis
Chronic incisional pain 1 year after surgery Chronic incisional pain
Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device 30 days after surgery Major vascular complications at 30-days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device)
Total mortality 1 year after surgery Total mortality
Cardiac transplant 1 year after surgery Cardiac transplant
Congestive heart failure 1 year after surgery Congestive heart failure
Frailty 1 year after surgery Frailty assessed by PRISMA-7 questionnaire
Implantation of mechanical assist device 1 year after surgery Implantation of mechanical assist device
Vascular mortality 1 year after surgery death due to vascular cause
Myocardial infarction 1 year after surgery Myocardial infarction
Non-fatal cardiac arrest 1 year after surgery Non-fatal cardiac arrest
Deep venous thrombosis 1 year after surgery Deep venous thrombosis
Repeat cardiac revascularization procedures 1 year after surgery Repeat cardiac revascularization procedures
Infection 1 year after surgery Infection (including sternal, sepsis, pneumonia)
Re-hospitalization for a vascular reason 1 year after surgery Re-hospitalization for a vascular reason
Stroke 1 year after surgery Stroke
Major bleeding 1 year after surgery Major bleeding
Trial Locations
- Locations (24)
Essex Cardiothoracic Centre, Basildon and Thurrock University NHS Trust
🇬🇧Basildon, Essex, United Kingdom
Hospital de Clínicas de Porto Alegre - HCPA
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
First Teaching Hospital
🇨🇳XinJiang, China
Santa Maria Hospital, GVM Care and Research
🇮🇹Bari, Italy
San Raffaele Scientific Institute
🇮🇹Milan, Italy
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Institut Jantung Negara Sdn. Bhd.
🇲🇾Kuala Lumpur, Malaysia
Department of Cardiovascular Surgery, Medical University of Gdansk
🇵🇱Gdańsk, Poland
Research Institute of Circulation Pathology
🇷🇺Novosibirsk, Russian Federation
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Liverpool Heart and Chest Hospital NHS Foundation Trust
🇬🇧Liverpool, Merseyside, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
INCOR
🇧🇷São Paulo, Brazil
Instituto de Cardiologia do RS
🇧🇷Porto Alegre, RS, Brazil
University of Bari "Aldo Moro"
🇮🇹Bari, Italy
BHF Centre of Cardiovascular Science, University of Edinburgh
🇬🇧Edinburgh, United Kingdom
Federal State Budgetary Institution "Research Institute for Complex Issues of Cardiovascular Diseases"
🇷🇺Kemerovo, Russian Federation
Ronald Reagan Medical Centre, UCLA
🇺🇸Los Angeles, California, United States
Blackpool Teaching Hospitals NHS Foundation Trust
🇬🇧Blackpool, Lancashire, United Kingdom
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong, SAR, Hong Kong