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Diastolic Dysfunction and Atrial Fibrillation in CABG Surgery

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ClinicalTrials.gov Identifier: NCT00188903
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 5, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Left ventricular (LV) diastolic dysfunction is a common manifestation of heart disease that is responsible for significant morbidity and mortality.It is present when the ventricular filling is impaired as a result of delayed relaxation or decreased compliance. During Coronary artery bypass grafting (CABG) surgery, LV diastolic dysfunction is a frequent occurrence. Failure of the left ventricle to dilate normally causes an increase in LV filling pressure. Atrial fibrillation (AF) is a common complication after cardiac surgery affecting 20-30% of patients undergoing coronary revascularization procedures. AF is associated with significant morbidity and mortality and has been identified as a causative factor of increased length of both hospital and intensive care unit (ICU) stay after CABG surgery, resulting in increased resource utilization and medical care costs.The primary aim of this study is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.

Condition or disease Intervention/treatment
Heart Disease Atrial Fibrillation Procedure: Diastolic measurements during TEE

Study Design

Study Type : Observational
Estimated Enrollment : 250 participants
Time Perspective: Prospective
Official Title: Diastolic Dysfunction and Atrial Fibrillation in Patients Undergoing Coronary Revascularization Surgery
Study Start Date : March 2004
Primary Completion Date : November 2007
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: Diastolic measurements during TEE
    Transesophageal echocardiography with diastolic measurements

Outcome Measures

Primary Outcome Measures :
  1. Is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery. [ Time Frame: pre and post operative ]

Secondary Outcome Measures :
  1. Is to determine if diastolic dysfunction and AF are associated with increased perioperative cardiac morbidity and reduced event-free survival. [ Time Frame: post operative until discharge ]

Eligibility Criteria

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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
Elective coronary artery bypass graft patients either on or off pump in acute care centre
Criteria

Inclusion Criteria:

  • scheduled for elective CABG or OPCAB surgery
  • signed informed consent

Exclusion Criteria:

  • Patients with a history of previous heart surgery and/or undergoing valvular heart surgery.
  • Patients with preoperative atrial fibrillation.
  • Patients in whom TEE is contraindicated.
Contacts and Locations

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): NCT00188903


Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: George N Djaiani, MD Toronto General Hospital, Univsersity Health Network
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Djaiani, Toronto General Hospital, University Health Network
ClinicalTrials.gov Identifier: NCT00188903     History of Changes
Other Study ID Numbers: UHN REB 03-0873-A
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 5, 2010
Last Verified: April 2008

Keywords provided by University Health Network, Toronto:
Cardiac Surgery
Diastolic Dysfunction
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes