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Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Population Health Research Institute
Sponsor:
Collaborator:
Abbott Diagnostics Division
Information provided by (Responsible Party):
Andre Lamy, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01842568
First received: April 17, 2013
Last updated: August 19, 2014
Last verified: August 2014

April 17, 2013
August 19, 2014
May 2013
January 2017   (final data collection date for primary outcome measure)
  • All-cause mortality at 30-days after surgery [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    All-cause mortality at 30-days after surgery
  • Myocardial injuries that were not identified clinically during the first 5 days after surgery [ Time Frame: 5 days after surgery ] [ Designated as safety issue: No ]
    Myocardial injuries that were not identified clinically during the first 5 days after surgery
  • Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    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)
  • Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    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)
Same as current
Complete list of historical versions of study NCT01842568 on ClinicalTrials.gov Archive Site
  • Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Total mortality
  • Total mortality [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Total mortality
  • Vascular mortality [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    death due to vascular cause
  • Vascular mortality [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    death due to vascular cause
  • Myocardial infarction [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Myocardial infarction
  • Myocardial infarction [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Myocardial infarction
  • Non-fatal cardiac arrest [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Non-fatal cardiac arrest
  • Non-fatal cardiac arrest [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Non-fatal cardiac arrest
  • Stroke [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Stroke
  • Stroke [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Stroke
  • Implantation of mechanical assist device [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Implantation of mechanical assist device
  • Implantation of mechanical assist device [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Implantation of mechanical assist device
  • Cardiac transplant [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Cardiac transplant
  • Cardiac transplant [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Cardiac transplant
  • Repeat cardiac revascularization procedures [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Repeat cardiac revascularization procedures
  • Repeat cardiac revascularization procedures [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Repeat cardiac revascularization procedures
  • Congestive heart failure [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Congestive heart failure
  • Congestive heart failure [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Congestive heart failure
  • New atrial fibrillation [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    New clinically important atrial fibrillation
  • New atrial fibrillation [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    New clinically important atrial fibrillation
  • Pulmonary embolus [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Pulmonary embolus
  • Pulmonary embolus [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Pulmonary embolus
  • Deep venous thrombosis [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Deep venous thrombosis
  • Deep venous thrombosis [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Deep venous thrombosis
  • Major bleeding [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Major bleeding
  • Major bleeding [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Major bleeding
  • New dialysis [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    New dialysis
  • New dialysis [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    New dialysis
  • Infection [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Infection (including sternal, sepsis, pneumonia)
  • Infection [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Infection (including sternal, sepsis, pneumonia)
  • Re-hospitalization for a vascular reason [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Re-hospitalization for a vascular reason
  • Re-hospitalization for a vascular reason [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Re-hospitalization for a vascular reason
  • Chronic incisional pain [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Chronic incisional pain
  • Chronic incisional pain [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Chronic incisional pain
  • Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Total mortality
  • Total mortality [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Total mortality
  • Vascular mortality [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    death due to vascular cause
  • Vascular mortality [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    death due to vascular cause
  • Myocardial infarction [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Myocardial infarction
  • Myocardial infarction [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Myocardial infarction
  • Non-fatal cardiac arrest [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Non-fatal cardiac arrest
  • Non-fatal cardiac arrest [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Non-fatal cardiac arrest
  • Stroke [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Stroke
  • Stroke [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Stroke
  • Implantation of mechanical assist device [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Implantation of mechanical assist device
  • Implantation of mechanical assist device [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Implantation of mechanical assist device
  • Cardiac transplant [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Cardiac transplant
  • Cardiac transplant [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Cardiac transplant
  • Repeat cardiac revascularization procedures [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Repeat cardiac revascularization procedures
  • Repeat cardiac revascularization procedures [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Repeat cardiac revascularization procedures
  • Congestive heart failure [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Congestive heart failure
  • Congestive heart failure [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Congestive heart failure
  • New atrial fibrillation [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    New clinically important atrial fibrillation
  • New atrial fibrillation [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    New clinically important atrial fibrillation
  • Pulmonary embolus [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Pulmonary embolus
  • Pulmonary embolus [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Pulmonary embolus
  • Deep venous thrombosis [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Deep venous thrombosis
  • Deep venous thrombosis [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Deep venous thrombosis
  • Major bleeding [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Major bleeding
  • Major bleeding [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Major bleeding
  • New dialysis [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    New dialysis
  • New dialysis [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    New dialysis
  • Infection [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Infection (inclusing sternal, sepsis, pneumonia)
  • Infection [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Infection (including sternal, sepsis, pneumonia)
  • Re-hospitalization for a vascular reason [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Re-hospitalization for a vascular reason
  • Re-hospitalization for a vascular reason [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Re-hospitalization for a vascular reason
  • Chronic incisional pain [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Chronic incisional pain
  • Chronic incisional pain [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Chronic incisional pain
Not Provided
Not Provided
 
Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients who have undergone cardiac surgery who are at least 18 years of age.

  • Vascular Death
  • Myocardial Infarction
  • Stroke
  • Cardiac Surgery
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15000
December 2017
January 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Valerie Dunlop 905-527-4322 ext 40675 valerie.dunlop@phri.ca
Canada,   Hong Kong,   Malaysia,   Spain
 
NCT01842568
VISION Cardiac Surgery
No
Andre Lamy, Population Health Research Institute
Population Health Research Institute
Abbott Diagnostics Division
Study Chair: P.J. Devereaux, MD, PhD McMaster University
Principal Investigator: Andre Lamy, MD McMaster University
Population Health Research Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP