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
  Purpose

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
Vascular Death
Myocardial Infarction
Stroke
Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 15000
Study Start Date: May 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842568

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

Locations
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         
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         
Malaysia
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         
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Maria Luz Maestre, M.D    93 553 75 41    mmaestre@santpau.cat   
Principal Investigator: Maria Luz Maestre, MD         
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
  More Information

No publications provided

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
Study First Received: April 17, 2013
Last Updated: August 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014