Diastolic Dysfunction and Atrial Fibrillation in CABG Surgery

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188903
First received: September 13, 2005
Last updated: August 3, 2010
Last verified: April 2008
  Purpose

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 Intervention
Heart Disease
Atrial Fibrillation
Procedure: Diastolic measurements during TEE

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Diastolic Dysfunction and Atrial Fibrillation in Patients Undergoing Coronary Revascularization Surgery

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: March 2004
Study Completion Date: March 2010
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Diastolic measurements during TEE
    Transesophageal echocardiography with diastolic measurements
  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

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
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: 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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: August 3, 2010
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on September 22, 2014