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Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01842568
Recruitment Status : Recruiting
First Posted : April 29, 2013
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
Abbott Diagnostics Division
Information provided by (Responsible Party):
Andre Lamy, 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.


Condition or disease
Vascular Death Myocardial Infarction Stroke Cardiac Surgery

Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
Study Start Date : May 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources




Primary Outcome Measures :
  1. All-cause mortality at 30-days after surgery [ Time Frame: 30 days after surgery ]
    All-cause mortality at 30-days after surgery

  2. Myocardial injuries that were not identified clinically during the first 5 days after surgery [ Time Frame: 5 days after surgery ]
    Myocardial injuries that were not identified clinically during the first 5 days after surgery

  3. Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device [ Time Frame: 30 days after surgery ]
    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)

  4. Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device [ Time Frame: 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 :
  1. Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device [ Time Frame: 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)

  2. Total mortality [ Time Frame: 30 days after surgery ]
    Total mortality

  3. Total mortality [ Time Frame: 1 year after surgery ]
    Total mortality

  4. Vascular mortality [ Time Frame: 30 days after surgery ]
    death due to vascular cause

  5. Vascular mortality [ Time Frame: 1 year after surgery ]
    death due to vascular cause

  6. Myocardial infarction [ Time Frame: 30 days after surgery ]
    Myocardial infarction

  7. Myocardial infarction [ Time Frame: 1 year after surgery ]
    Myocardial infarction

  8. Non-fatal cardiac arrest [ Time Frame: 30 days after surgery ]
    Non-fatal cardiac arrest

  9. Non-fatal cardiac arrest [ Time Frame: 1 year after surgery ]
    Non-fatal cardiac arrest

  10. Stroke [ Time Frame: 30 days after surgery ]
    Stroke

  11. Stroke [ Time Frame: 1 year after surgery ]
    Stroke

  12. Implantation of mechanical assist device [ Time Frame: 30 days after surgery ]
    Implantation of mechanical assist device

  13. Implantation of mechanical assist device [ Time Frame: 1 year after surgery ]
    Implantation of mechanical assist device

  14. Cardiac transplant [ Time Frame: 30 days after surgery ]
    Cardiac transplant

  15. Cardiac transplant [ Time Frame: 1 year after surgery ]
    Cardiac transplant

  16. Repeat cardiac revascularization procedures [ Time Frame: 30 days after surgery ]
    Repeat cardiac revascularization procedures

  17. Repeat cardiac revascularization procedures [ Time Frame: 1 year after surgery ]
    Repeat cardiac revascularization procedures

  18. Congestive heart failure [ Time Frame: 30 days after surgery ]
    Congestive heart failure

  19. Congestive heart failure [ Time Frame: 1 year after surgery ]
    Congestive heart failure

  20. New atrial fibrillation [ Time Frame: 30 days after surgery ]
    New clinically important atrial fibrillation

  21. New atrial fibrillation [ Time Frame: 1 year after surgery ]
    New clinically important atrial fibrillation

  22. Pulmonary embolus [ Time Frame: 30 days after surgery ]
    Pulmonary embolus

  23. Pulmonary embolus [ Time Frame: 1 year after surgery ]
    Pulmonary embolus

  24. Deep venous thrombosis [ Time Frame: 30 days after surgery ]
    Deep venous thrombosis

  25. Deep venous thrombosis [ Time Frame: 1 year after surgery ]
    Deep venous thrombosis

  26. Major bleeding [ Time Frame: 30 days after surgery ]
    Major bleeding

  27. Major bleeding [ Time Frame: 1 year after surgery ]
    Major bleeding

  28. New dialysis [ Time Frame: 30 days after surgery ]
    New dialysis

  29. New dialysis [ Time Frame: 1 year after surgery ]
    New dialysis

  30. Infection [ Time Frame: 30 days after surgery ]
    Infection (including sternal, sepsis, pneumonia)

  31. Infection [ Time Frame: 1 year after surgery ]
    Infection (including sternal, sepsis, pneumonia)

  32. Re-hospitalization for a vascular reason [ Time Frame: 30 days after surgery ]
    Re-hospitalization for a vascular reason

  33. Re-hospitalization for a vascular reason [ Time Frame: 1 year after surgery ]
    Re-hospitalization for a vascular reason

  34. Chronic incisional pain [ Time Frame: 30 days after surgery ]
    Chronic incisional pain

  35. Chronic incisional pain [ Time Frame: 1 year after surgery ]
    Chronic incisional pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone cardiac surgery who are at least 18 years of age.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842568


Contacts
Contact: Valerie Dunlop 905-527-4322 ext 40675 valerie.dunlop@phri.ca

Locations
United States, California
Ronald Reagan Medical Centre, UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Aman Mahajan, MD    310-267-8680    amahajan@mednet.ucla.edu   
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Graham Hillis, M.D    +61293362699    ghillis@georgeinstitute.org.au   
Principal Investigator: Graham Hillis, M.D         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Andre Lamy, MD    905-527-4322 ext 40324    lamya@mcmaster.ca   
Contact: P.J. Devereaux, MD, PhD    905-527-4322 ext 40654    philipj@mcmaster.ca   
Principal Investigator: Andre Lamy, MD         
Sub-Investigator: Richard Whitlock, MD, PhD         
Kingston General Hospital Recruiting
Kingston, Ontario, Canada
Contact: Rene Allard, MD    (613) 549-6666 ext 7827    allardr@kgh.kari.net   
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Stephen Choi, MD    1-416-480-6100 ext 4864    stephen.choi@sunnybrook.ca   
China
First Teaching Hospital Recruiting
XinJiang, China
Contact: Zheng Hong, MD    +86 13565996995    xjzhenghong@aliyun.com   
Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong, SAR, Hong Kong, NT
Contact: Matthew Chan, MD    +852 2632 2736    mtvchan@cuhk.edu.hk   
Contact: Beaker Fung    85226321905    beaker@cuhk.edu.hk   
Principal Investigator: Matthew Chan, MD         
Italy
University of Bari "Aldo Moro" Recruiting
Bari, Italy
Contact: Domenico Paparella, MD    00390805595076    domenico.paparella@uniba.it   
Principal Investigator: Domenico Paparella, MD         
Malaysia
Institut Jantung Negara Sdn. Bhd. Recruiting
Kuala Lumpur, Malaysia, 50400
Contact: Suhaini Kadiman, MD    +603-26178522    suhaini@ijn.com.my   
University of Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Chew Yin Wang, MD       wangcy@um.edu.my   
Contact: Ching Yen Chong       chingyen.chong@gmail.com   
Principal Investigator: Chew Yin Wang, MD         
Russian Federation
Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Vladimir Lomivorotov, MD    7 (913) 916 41 03    vvlom@mail.ru   
Spain
Hospital de la Santa Creu i Sant Pau Active, not recruiting
Barcelona, Spain, 08025
United Kingdom
BHF Centre of Cardiovascular Science, University of Edinburgh Recruiting
Edinburgh, United Kingdom
Contact: Nick Mills, MD    +44 (0) 131 242 6515    nick.mills@ed.ac.uk   
Sponsors and Collaborators
Population Health Research Institute
Abbott Diagnostics Division
Investigators
Study Chair: P.J. Devereaux, MD, PhD McMaster University
Principal Investigator: Andre Lamy, MD McMaster University

Responsible Party: Andre Lamy, Professor and Cardiac Surgeon, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01842568     History of Changes
Other Study ID Numbers: VISION Cardiac Surgery
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Andre Lamy, Population Health Research Institute:
Cardiac surgery
Troponin
Vascular events
Myocardial injury
Observational cohort study
Public health

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases